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BACKGROUND AND AIMS: Noninvasive tools assessing steatosis, such as ultrasonography-based 2D-attenuation imaging (ATI), are needed to tackle the worldwide burden of steatotic liver disease. This one-stage individual patient data (IPD) meta-analysis aimed to create an ATI-based steatosis grading system. APPROACH AND RESULTS: A systematic review (EMBASE + MEDLINE, 2018-2022) identified studies, including patients with histologically or magnetic resonance imaging proton-density fat fraction (MRI-PDFF)-verified ATI for grading steatosis (S0 to S3). One-stage IPD meta-analyses were conducted using generalized mixed models with a random study-specific intercept. Created ATI-based steatosis grading system (aS0 to aS3) was externally validated on a prospective cohort of patients with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (n=174, histologically and MRI-PDFF-verified steatosis). Eleven enrolled studies included 1374 patients, classified into S0, S1, S2, and S3 in 45.4%, 35.0%, 9.3%, and 10.3% of the cases. ATI was correlated with histological steatosis ( r = 0.60; 95% CI: 0.52, 0.67; p < 0.001) and MRI-PDFF ( r = 0.70; 95% CI: 0.66, 0.73; p < 0.001) but not with liver stiffness ( r = 0.03; 95% CI: -0.04, 0.11, p = 0.343). Steatosis grade was an independent factor associated with ATI (coefficient: 0.24; 95% CI: [0.22, 0.26]; p < 0.001). ATI marginal means within S0, S1, S2, and S3 subpopulations were 0.59 (95% CI: [0.58, 0.61]), 0.69 (95% CI [0.67, 0.71]), 0.78 (95% CI: [0.76, 0.81]), and 0.85 (95% CI: [0.83, 0.88]) dB/cm/MHz; all contrasts between grades were significant ( p < 0.0001). Three ATI thresholds were calibrated to create a new ATI-based steatosis grading system (aS0 to aS3, cutoffs: 0.66, 0.73, and 0.81 dB/cm/MHz). Its external validation showed Obuchowski measures of 0.84 ± 0.02 and 0.82 ± 0.02 with histologically based and MRI-PDFF-based references. CONCLUSIONS: ATI is a reliable, noninvasive marker of steatosis. This validated ATI-based steatosis grading system could be valuable in assessing patients with metabolic dysfunction-associated steatotic liver disease.
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BACKGROUND & AIMS: Ultrasonography (US) is recommended for HCC surveillance in high-risk patients but has limited performance in detecting early-stage HCC. We aimed to compare the diagnostic performance of biannual US and annual non-contrast abbreviated magnetic resonance imaging (NC-AMRI) as HCC surveillance modalities in high-risk patients. METHODS: This prospective, multicenter cohort study enrolled participants with an estimated annual risk of HCC greater than 5% between October 2015 and April 2017. Participants underwent six rounds of HCC surveillance at 6-month intervals, with both US and NC-AMRI at rounds 1, 3, and 5, and only US at rounds 2, 4, and 6. The sensitivity, diagnostic yield (DY), and false referral rate (FRR) for HCC detection by US and NC-AMRI were compared. RESULTS: In total, 208 participants underwent 980 US and 516 NC-AMRI examinations during 30 months of follow-up. Among them, 34 HCCs were diagnosed in 31 participants, with 20 (64.5%) classified as very early-stage and 11 (35.5%) as early-stage HCC. The sensitivity of annual NC-AMRI (71.0%, 22/31) was marginally higher than that of biannual US (45.2%, 14/31; p = 0.077). NC-AMRI showed a significantly higher DY than US (4.26% vs. 1.43%, p <0.001), with a similar FRR (2.91% vs. 3.06%, p = 0.885). A simulation of alternating US and NC-AMRI at 6-month intervals yielded a sensitivity of 83.9% (26/31), significantly exceeding that of biannual US (p = 0.006). CONCLUSIONS: Annual NC-AMRI showed a marginally higher sensitivity than biannual US for HCC detection in high-risk patients. The DY of annual NC-AMRI was significantly higher than that of biannual US, without increasing the FRR. Thus, alternating US and NC-AMRI at 6-month intervals could be an optimal surveillance strategy for high-risk patients. IMPACT AND IMPLICATIONS: Current guidelines permit the use of magnetic resonance imaging (MRI) as a surveillance tool for hepatocellular carcinoma in patients in whom ultrasonography (US) is inadequate. However, the specific indications, imaging sequences, and intervals for MRI surveillance remain unclear. In our study, we found that annual non-contrast abbreviated MRI exhibited marginally higher sensitivity and significantly better diagnostic yield than biannual US in patients at high risk of hepatocellular carcinoma. Alternating US and non-contrast abbreviated MRI at 6-month intervals led to significantly improved sensitivity compared to biannual US, making it a potentially optimal surveillance strategy for high-risk patients. GOV IDENTIFIER: NCT02551250.
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INTRODUCTION: Visceral obesity is a risk factor for reflux esophagitis (RE). We investigated the risk of RE according to visceral adipose tissue (VAT) measured by deep neural network architecture using computed tomography (CT) and evaluated the longitudinal association between abdominal adipose tissue changes and the disease course of RE. METHODS: Individuals receiving health checkups who underwent esophagogastroduodenoscopy (EGD) and abdominal CT at Seoul National University Healthcare System Gangnam Center between 2015 and 2016 were included. Visceral and subcutaneous adipose tissue areas and volumes were measured using a deep neural network architecture and CT. The association between the abdominal adipose tissue area and volume and the risk of RE was evaluated. Participants who underwent follow-up EGD and abdominal CT were selected; the effects of changes in abdominal adipose tissue area and volume on RE endoscopic grade were investigated using Cox proportional hazards regression. RESULTS: We enrolled 6,570 patients who underwent EGD and abdominal CT on the same day. RE was associated with male sex, hypertension, diabetes, excessive alcohol intake, current smoking status, and levels of physical activity. The VAT area and volume increased the risk of RE dose-dependently. A decreasing VAT volume was significantly associated with improvement in RE endoscopic grade (hazard ratio: 3.22, 95% confidence interval: 1.82-5.71). Changes in subcutaneous adipose tissue volume and the disease course of RE were not significantly correlated. DISCUSSION: Visceral obesity is strongly associated with RE. VAT volume reduction was prospectively associated with improvement in RE endoscopic grade dose-dependently. Visceral obesity is a potential target for RE treatment.
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Endoscopia do Sistema Digestório , Esofagite Péptica , Gordura Intra-Abdominal , Tomografia Computadorizada por Raios X , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Gordura Intra-Abdominal/diagnóstico por imagem , Gordura Intra-Abdominal/patologia , Esofagite Péptica/diagnóstico por imagem , Esofagite Péptica/patologia , Endoscopia do Sistema Digestório/métodos , Fatores de Risco , Adulto , Obesidade Abdominal/complicações , Obesidade Abdominal/diagnóstico por imagem , Redes Neurais de Computação , Idoso , Estudos Retrospectivos , Índice de Gravidade de DoençaRESUMO
The American College of Radiology Liver Imaging Reporting and Data System (LI-RADS) standardizes the imaging technique, reporting lexicon, disease categorization, and management for patients with or at risk for hepatocellular carcinoma (HCC). LI-RADS encompasses HCC surveillance with US; HCC diagnosis with CT, MRI, or contrast-enhanced US (CEUS); and treatment response assessment (TRA) with CT or MRI. LI-RADS was recently expanded to include CEUS TRA after nonradiation locoregional therapy or surgical resection. This report provides an overview of LI-RADS CEUS Nonradiation TRA v2024, including a lexicon of imaging findings, techniques, and imaging criteria for posttreatment tumor viability assessment. LI-RADS CEUS Nonradiation TRA v2024 takes into consideration differences in the CEUS appearance of viable tumor and posttreatment changes within and in close proximity to a treated lesion. Due to the high sensitivity of CEUS to vascular flow, posttreatment reactive changes commonly manifest as areas of abnormal perilesional enhancement without washout, especially in the first 3 months after treatment. To improve the accuracy of CEUS for nonradiation TRA, different diagnostic criteria are used to evaluate tumor viability within and outside of the treated lesion margin. Broader criteria for intralesional enhancement increase sensitivity for tumor viability detection. Stricter criteria for perilesional enhancement limit miscategorization of posttreatment reactive changes as viable tumor. Finally, the TRA algorithm reconciles intralesional and perilesional tumor viability assessment and assigns a single LI-RADS treatment response (LR-TR) category: LR-TR nonviable, LR-TR equivocal, or LR-TR viable.
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Carcinoma Hepatocelular , Meios de Contraste , Neoplasias Hepáticas , Ultrassonografia , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/radioterapia , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/radioterapia , Ultrassonografia/métodos , Sistemas de Informação em Radiologia , Fígado/diagnóstico por imagem , Resultado do TratamentoRESUMO
Background Noninvasive diagnostic guidelines for hepatocellular carcinoma (HCC) vary across different global geographic areas, especially regarding criteria about gadoxetic acid-enhanced MRI. Purpose To compare the diagnostic performance of four different international HCC diagnosis guidelines and readers' judgment in diagnosing HCC using gadoxetic acid-enhanced MRI in patients at high risk for HCC. Materials and Methods This retrospective study included patients who had not undergone treatment, were at risk for HCC, and who underwent gadoxetic acid-enhanced MRI from January 2015 to June 2018 from 11 tertiary hospitals in South Korea. Four radiologists independently reviewed focal liver lesions (FLLs) according to four guidelines: American Association for the Study of Liver Diseases (AASLD)/Liver Imaging Reporting and Data System (LI-RADS), Korean Liver Cancer Association-National Cancer Center (KLCA-NCC), European Association for the Study of the Liver (EASL), and Asian Pacific Association for the Study of the Liver (APASL). Reader judgment (HCC or not HCC) was also recorded. Malignant FLLs were confirmed at pathology, and histologic and clinical follow-up data were used for benign FLLs. The guidelines' diagnostic performance was compared using generalized estimating equations. Additionally, the diagnostic odds ratio was assessed. Results A total of 2445 FLLs (median size, 27.4 mm) were analyzed in 2237 patients (mean age, 59 years ± 11 [SD]; 1666 male patients); 69.3% (1694 of 2445) were HCCs. KLCA-NCC showed the highest accuracy (80.0%; 95% CI: 78.7, 81.2; P = .001), with high sensitivity in Eastern guidelines (APASL, 89.1% [95% CI: 87.8, 90.3]; KLCA-NCC, 78.2% [95% CI: 76.6, 79.7]) and high specificity in Western guidelines (AASLD/LI-RADS, 89.6% [95% CI: 87.8, 91.2]; EASL, 88.1% [95% CI: 86.2, 89.9]) (P = .001). The diagnostic odds ratios were 20.7 (95% CI: 17.0, 25.3) for AASLD/LI-RADS, 18.9 (95% CI: 15.8, 22.6) for KLCA-NCC, 16.8 (95% CI: 13.8, 20.4) for EASL, and 8.9 (95% CI: 7.4, 10.7) for APASL. The readers' judgment demonstrated higher accuracy than that of the guidelines (accuracy, 86.0%; 95% CI: 84.9, 86.9; P = .001). Conclusion Among four different international HCC diagnosis guidelines, Eastern guidelines demonstrated higher sensitivity, whereas Western guidelines displayed higher specificity. KLCA-NCC achieved the highest accuracy, and AASLD/LI-RADS exhibited the highest diagnostic odds ratio. © RSNA, 2024 Supplemental material is available for this article.
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Carcinoma Hepatocelular , Gadolínio DTPA , Neoplasias Hepáticas , Humanos , Masculino , Pessoa de Meia-Idade , Carcinoma Hepatocelular/diagnóstico por imagem , Estudos Retrospectivos , Neoplasias Hepáticas/diagnóstico por imagem , Imageamento por Ressonância MagnéticaRESUMO
OBJECTIVES: To identify MRI features for differentiating type 2 from type 1 intraductal papillary neoplasms of bile duct (IPNB) and assessing malignant potential of IPNB. METHODS: This retrospective study included 60 patients with surgically proven IPNB who had undergone preoperative MRI between January 2007 and December 2020. All surgical specimens were reviewed retrospectively to classify types 1 and 2 IPNBs and assess tumor grade. Significant MRI features for differentiating type 2 (n = 40) from type 1 IPNB (n = 20); and for IPNB with an associated invasive carcinoma (n = 43) from intraepithelial neoplasia (n = 17) were determined using logistic regression analysis. RESULTS: An associated invasive carcinoma was more frequently found in type 2 than in type 1 IPNB (85.0% [34/40] vs. 45.0% [9/20], p = 0.003). At univariable analysis, MRI features including extrahepatic location, no dilatation of tumor-bearing segment of bile duct, isolated upstream bile duct dilatation, and single lesion were associated with type 2 IPNB (all p ≤ 0.012). At multivariable analysis, significant MRI findings for differentiating type 2 from type 1 IPNB were extrahepatic location and no dilatation of tumor-bearing segment of bile duct (odds ratio [OR], 7.24 and 46.40, respectively). At univariable and multivariable analysis, tumor size ≥ 2.5 cm (OR, 8.45), bile duct wall thickening (OR, 4.82), and irregular polypoid or nodular tumor shape (OR, 6.44) were significant MRI features for differentiating IPNB with an associated invasive carcinoma from IPNB with intraepithelial neoplasia. CONCLUSION: MRI with MR cholangiopancreatography may be helpful in differentiating type 2 IPNB from type 1 IPNB and assessing malignant potential of IPNB. CLINICAL RELEVANCE STATEMENT: Preoperative MRI with MR cholangiopancreatography may be helpful in differentiating type 2 intraductal papillary neoplasms of bile duct (IPNB) from type 1 IPNB and assessing malignant potential of IPNB. KEY POINTS: ⢠In terms of tumor grade, the incidence of invasive carcinoma was significantly higher in type 2 intraductal papillary neoplasm of the bile duct (IPNB) than in type 1 IPNB. ⢠At MRI, extrahepatic location and no dilatation of tumor-bearing segment are significant features for differentiating type 2 IPNBs from type 1 IPNBs. ⢠At MRI, large tumor size, bile duct wall thickening, and irregular polypoid or nodular tumor shape are significant features for differentiating IPNB with an associated invasive carcinoma from IPNB with intraepithelial neoplasia.
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Neoplasias dos Ductos Biliares , Imageamento por Ressonância Magnética , Humanos , Masculino , Feminino , Imageamento por Ressonância Magnética/métodos , Estudos Retrospectivos , Neoplasias dos Ductos Biliares/diagnóstico por imagem , Neoplasias dos Ductos Biliares/patologia , Pessoa de Meia-Idade , Idoso , Diagnóstico Diferencial , Adulto , Idoso de 80 Anos ou maisRESUMO
OBJECTIVE: To investigate whether a deep learning (DL) controlled aliasing in parallel imaging results in higher acceleration (CAIPIRINHA)-volumetric interpolated breath-hold examination (VIBE) technique can improve image quality, lesion conspicuity, and lesion detection compared to a standard CAIPIRINHA-VIBE technique in gadoxetic acid-enhanced liver MRI. METHODS: This retrospective single-center study included 168 patients who underwent gadoxetic acid-enhanced liver MRI at 3 T using both standard CAIPIRINHA-VIBE and DL CAIPIRINHA-VIBE techniques on pre-contrast and hepatobiliary phase (HBP) images. Additionally, high-resolution (HR) DL CAIPIRINHA-VIBE was obtained with 1-mm slice thickness on the HBP. Three abdominal radiologists independently assessed the image quality and lesion conspicuity of pre-contrast and HBP images. Statistical analyses involved the Wilcoxon signed-rank test for image quality assessment and the generalized estimation equation for lesion conspicuity and detection evaluation. RESULTS: DL and HR-DL CAIPIRINHA-VIBE demonstrated significantly improved overall image quality and reduced artifacts on pre-contrast and HBP images compared to standard CAIPIRINHA-VIBE (p < 0.001), with a shorter acquisition time (DL vs standard, 11 s vs 17 s). However, the former presented a more synthetic appearance (both p < 0.05). HR-DL CAIPIRINHA-VIBE showed superior lesion conspicuity to standard and DL CAIPIRINHA-VIBE on HBP images (p < 0.001). Moreover, HR-DL CAIPIRINHA-VIBE exhibited a significantly higher detection rate of small (< 2 cm) solid focal liver lesions (FLLs) on HBP images compared to standard CAIPIRINHA-VIBE (92.5% vs 87.4%; odds ratio = 1.83; p = 0.036). CONCLUSION: DL and HR-DL CAIPIRINHA-VIBE achieved superior image quality compared to standard CAIPIRINHA-VIBE. Additionally, HR-DL CAIPIRINHA-VIBE improved the lesion conspicuity and detection of small solid FLLs. DL and HR-DL CAIPIRINHA-VIBE hold the potential clinical utility for gadoxetic acid-enhanced liver MRI. CLINICAL RELEVANCE STATEMENT: DL and HR-DL CAIPIRINHA-VIBE hold promise as potential alternatives to standard CAIPIRINHA-VIBE in routine clinical liver MRI, improving the image quality and lesion conspicuity, enhancing the detection of small (< 2 cm) solid focal liver lesions, and reducing the acquisition time. KEY POINTS: ⢠DL and HR-DL CAIPIRINHA-VIBE demonstrated improved overall image quality and reduced artifacts on pre-contrast and HBP images compared to standard CAIPIRINHA-VIBE, in addition to a shorter acquisition time. ⢠DL and HR-DL CAIPIRINHA-VIBE yielded a more synthetic appearance than standard CAIPIRINHA-VIBE. ⢠HR-DL CAIPIRINHA-VIBE showed improved lesion conspicuity than standard CAIPIRINHA-VIBE on HBP images, with a higher detection of small (< 2 cm) solid focal liver lesions.
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OBJECTIVES: This study aimed to evaluate the potential of deep learning (DL)-assisted automated three-dimensional quantitative tumor burden at MRI to predict postoperative early recurrence (ER) of hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This was a single-center retrospective study enrolling patients who underwent resection for BCLC A and B HCC and preoperative contrast-enhanced MRI. Quantitative total tumor volume (cm3) and total tumor burden (TTB, %) were obtained using a DL automated segmentation tool. Radiologists' visual assessment was used to ensure the quality control of automated segmentation. The prognostic value of clinicopathological variables and tumor burden-related parameters for ER was determined by Cox regression analyses. RESULTS: A total of 592 patients were included, with 525 and 67 patients assigned to BCLC A and B, respectively (2-year ER rate: 30.0% vs. 45.3%; hazard ratio (HR) = 1.8; p = 0.007). TTB was the most important predictor of ER (HR = 2.2; p < 0.001). Using 6.84% as the threshold of TTB, two ER risk strata were obtained in overall (p < 0.001), BCLC A (p < 0.001), and BCLC B (p = 0.027) patients, respectively. The BCLC B low-TTB patients had a similar risk for ER to BCLC A patients and thus were reassigned to a BCLC An stage; whilst the BCLC B high-TTB patients remained in a BCLC Bn stage. The 2-year ER rate was 30.5% for BCLC An patients vs. 58.1% for BCLC Bn patients (HR = 2.8; p < 0.001). CONCLUSIONS: TTB determined by DL-based automated segmentation at MRI was a predictive biomarker for postoperative ER and facilitated refined subcategorization of patients within BCLC stages A and B. CLINICAL RELEVANCE STATEMENT: Total tumor burden derived by deep learning-based automated segmentation at MRI may serve as an imaging biomarker for predicting early recurrence, thereby improving subclassification of Barcelona Clinic Liver Cancer A and B hepatocellular carcinoma patients after hepatectomy. KEY POINTS: Total tumor burden (TTB) is important for Barcelona Clinic Liver Cancer (BCLC) staging, but is heterogenous. TTB derived by deep learning-based automated segmentation was predictive of postoperative early recurrence. Incorporating TTB into the BCLC algorithm resulted in successful subcategorization of BCLC A and B patients.
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BACKGROUND. Contrast-enhanced ultrasound (CEUS) with perfluorobutane has used varying protocols and diagnostic criteria for hepatocellular carcinoma (HCC). OBJECTIVE. The purpose of this article was to assess diagnostic performance for HCC of CEUS with perfluorobutane in high-risk patients using various criteria. METHODS. This retrospective post hoc study evaluating individual patient data from three earlier prospective studies from one hospital included 204 patients (136 men, 68 women; mean age, 63 ± 11 [SD] years) at high risk of HCC with 213 liver observations. Patients underwent CEUS using perfluorobutane from March 2019 to June 2022. Three radiologists (the examination's operator and two subsequent reviewers) independently interpreted examinations, assessing arterial, portal venous (arterial phase completion through 2 minutes), transitional (2-5 minutes after injection), and Kupffer (≥ 10 minutes after injection) phase findings. Six criteria for HCC were tested: 1, any arterial phase hyperenhancement (APHE) with Kupffer phase hypoenhancement; 2, nonrim APHE with Kupffer phase hypoenhancement; 3, nonrim APHE with portal venous washout; 4, nonrim APHE with portal venous washout and/or Kupffer phase hypoenhancement; 5, nonrim APHE with portal venous and/or transitional washout; 6, nonrim APHE with any of portal venous washout, transitional washout, or Kupffer phase hypoenhancement. Depending on the criteria, observations were instead deemed to be a non-HCC malignancy if showing rim APHE, early washout (at < 1 minute), or marked washout (at 2 minutes). Reference was pathology for malignant observations and pathology or imaging follow-up for benign observations. Diagnostic performance was assessed, pooling readers' data. RESULTS. Criterion 1 (no recognized features of non-HCC malignancy) had highest sensitivity (86.9%) but lowest specificity (43.2%) for HCC. Compared with nonrim APHE and portal venous washout (criterion 3), the addition of Kupffer phase hypoenhancement (criterion 4), transitional washout (criterion 5), or either feature (criterion 6) significantly increased sensitivity (34.4% vs 62.6-64.2%) and accuracy (61.8% vs 75.1-76.5%), but significantly decreased specificity (98.5% vs 91.9-94.1%). Criteria 2, 4, 5, and 6 (all incorporating transitional washout and/or Kupffer phase hypoenhancement) showed no significant differences in sensitivity (62.6-64.2%), specificity (91.9-94.1%), or accuracy (75.1-76.5%). CONCLUSION. Recognition of features of non-HCC malignancy improved specificity for HCC. Incorporation of the findings of transitional washout and/or Kupffer phase hypoenhancement improved sensitivity and accuracy, albeit lowered specificity, versus arterial and portal venous findings alone, without further performance variation among criteria incorporating those two findings. CLINICAL IMPACT. Kupffer phase acquisition may be optional for observations classified as HCC or non-HCC malignancy by arterial, portal venous, and transitional phases.
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Carcinoma Hepatocelular , Fluorocarbonos , Neoplasias Hepáticas , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/patologia , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/patologia , Estudos Retrospectivos , Estudos Prospectivos , Meios de Contraste , Imageamento por Ressonância Magnética/métodos , Sensibilidade e Especificidade , Ultrassonografia/métodosRESUMO
The present study aims to explore the probable anti-adipogenesis effect of Dictyopteris divaricata (D. divaricata) in 3T3-L1 preadipocytes by regulating heme oxygenase-1 (HO-1). The extract of D. divaricata retarded lipid accretion and decreased triglyceride (TG) content in 3T3-L1 adipocytes but increased free glycerol levels. Treatment with the extract inhibited lipogenesis by inhibiting protein expressions of fatty acid synthase (FAS) and lipoprotein lipase (LPL), whereas lipolysis increased by activating phosphorylation of hormone-sensitive lipase (p-HSL) and AMP-activated protein kinase (p-AMPK). The extract inhibited adipocyte differentiation of 3T3-L1 preadipocytes through down-regulating adipogenic transcription factors, including peroxisome proliferator-activated receptor gamma (PPARγ) and CCAAT/enhancer-binding protein α (C/EBPα), and sterol regulatory element-binding protein 1 (SREBP1). This is attributed to the triggering of Wnt/ß-catenin signaling. In addition, this study found that treatment with the extract activated HO-1 expression. Pharmacological approaches revealed that treatment with Zinc Protoporphyrin (ZnPP), an HO-1 inhibitor, resulted in an increase in lipid accumulation and a decrease in free glycerol levels. Finally, three adipogenic transcription factors, such as PPARγ, C/EBPα, and SREBP1, restored their expression in the presence of ZnPP. Analysis of chemical constituents revealed that the extract of D. divaricata is rich in 1,4-benzenediol, 7-tetradecenal, fucosterol, and n-hexadecanoic acid, which are known to have multiple pharmacological properties.
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Adipogenia , Phaeophyceae , Animais , Camundongos , Lipólise , Células 3T3-L1 , Heme Oxigenase-1/metabolismo , PPAR gama/metabolismo , Glicerol/farmacologia , Glicerol/metabolismo , Diferenciação Celular , Adipócitos , Proteína alfa Estimuladora de Ligação a CCAAT , Fatores de Transcrição/metabolismo , Lipídeos/farmacologiaRESUMO
Background Quantitative US (QUS) using radiofrequency data analysis has been recently introduced for noninvasive evaluation of hepatic steatosis. Deep learning algorithms may improve the diagnostic performance of QUS for hepatic steatosis. Purpose To evaluate a two-dimensional (2D) convolutional neural network (CNN) algorithm using QUS parametric maps and B-mode images for diagnosis of hepatic steatosis, with the MRI-derived proton density fat fraction (PDFF) as the reference standard, in patients with nonalcoholic fatty liver disease (NAFLD). Materials and Methods: Consecutive adult participants with suspected NAFLD were prospectively enrolled at a single academic medical center from July 2020 to June 2021. Using radiofrequency data analysis, two QUS parameters (tissue attenuation imaging [TAI] and tissue scatter-distribution imaging [TSI]) were measured. On B-mode images, hepatic steatosis was graded using visual scoring (none, mild, moderate, or severe). Using B-mode images and two QUS parametric maps (TAI and TSI) as input data, the algorithm estimated the US fat fraction (USFF) as a percentage. The correlation between the USFF and MRI PDFF was evaluated using the Pearson correlation coefficient. The diagnostic performance of the USFF for hepatic steatosis (MRI PDFF ≥5%) was evaluated using receiver operating characteristic curve analysis and compared with that of TAI, TSI, and visual scoring. Results Overall, 173 participants (mean age, 51 years ± 14 [SD]; 96 men) were included, with 126 (73%) having hepatic steatosis (MRI PDFF ≥5%). USFF correlated strongly with MRI PDFF (Pearson r = 0.86, 95% CI: 0.82, 0.90; P < .001). For diagnosing hepatic steatosis (MRI PDFF ≥5%), the USFF yielded an area under the receiver operating characteristic curve of 0.97 (95% CI: 0.93, 0.99), higher than those of TAI, TSI, and visual scoring (P = .015, .006, and < .001, respectively), with a sensitivity of 90% (95% CI: 84, 95 [114 of 126]) and a specificity of 91% (95% CI: 80, 98 [43 of 47]) at a cutoff value of 5.7%. Conclusion A deep learning algorithm using quantitative US parametric maps and B-mode images accurately estimated the hepatic fat fraction and diagnosed hepatic steatosis in participants with nonalcoholic fatty liver disease. ClinicalTrials.gov registration nos. NCT04462562, NCT04180631 © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Sidhu and Fang in this issue.
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Hepatopatia Gordurosa não Alcoólica , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , Fígado/diagnóstico por imagem , Imageamento por Ressonância Magnética/métodos , Redes Neurais de Computação , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/diagnóstico por imagem , Estudos Prospectivos , Curva ROCRESUMO
Background Gadopiclenol is a macrocyclic gadolinium-based contrast agent (GBCA) with higher relaxivity compared with standard GBCAs, potentially allowing gadolinium dose reduction without decreasing efficacy. Purpose To investigate whether gadopiclenol at 0.05 mmol/kg is noninferior to gadobutrol at 0.1 mmol/kg for lesion visualization in body MRI. Materials and Methods A randomized, double-blind, crossover, phase 3 study was conducted between August 2019 and December 2020 at 33 centers in 11 countries. Adults with at least one suspected focal lesion in one of three different body regions (head and neck; breast, thorax, abdomen, or pelvis; or musculoskeletal system) underwent two contrast-enhanced MRI examinations, randomized to start with either gadopiclenol or gadobutrol. MRI examinations were read by three blinded expert readers for each respective body region. Readers rated border delineation, internal morphologic characteristics, and visual contrast enhancement. Three additional blinded readers assessed reader preference. For safety analysis, adverse events were recorded. The differences between gadopiclenol- and gadobutrol-enhanced MRI in terms of lesion visualization were analyzed with a generalized linear mixed model using a two-sided paired t test. Results Among 273 participants (mean age, 57 years ± 13 [SD]; 162 women) who underwent both gadopiclenol- and gadobutrol-enhanced MRI and had at least one correlating lesion, 260 participants without major protocol deviations were analyzed for noninferiority. Gadopiclenol was noninferior to gadobutrol for all qualitative visualization parameters and for all readers (lower limit 95% CI of the difference of at least -0.10, which was above the noninferiority margin [-0.35]; P < .001). For most participants (75%-83% [206-228 of 276]), readers reported no preference between gadopiclenol- and gadobutrol-enhanced images. Adverse events did not differ in frequency, intensity, type, or association with GBCA injection (12 of 288 participants receiving gadopiclenol and 16 of 290 receiving gadobutrol). Conclusion Gadopiclenol at 0.05 mmol/kg was comparable with gadobutrol at 0.1 mmol/kg for lesion evaluation at contrast-enhanced body MRI and had a similar safety profile. Clinical trial registration no. NCT03986138 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Bashir and Thomas in this issue.
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Neoplasias Encefálicas , Compostos Organometálicos , Adulto , Humanos , Feminino , Pessoa de Meia-Idade , Gadolínio/efeitos adversos , Neoplasias Encefálicas/patologia , Meios de Contraste , Imageamento por Ressonância Magnética/métodosRESUMO
Several major transplantation centers have used composite multimodality evaluation for the preoperative evaluation of potential living liver donors. This approach can be time-consuming and, although rare, can cause complications. We aimed to demonstrate the clinical feasibility of our comprehensive preoperative MR protocol for the preoperative assessment of living liver donor candidates instead of composite multimodality evaluation. Thirty-five consecutive living liver donor candidates underwent multiphasic liver CT and comprehensive donor protocol MR examinations for preoperative evaluation in a single large-volume liver transplantation (LT) center. Three blinded abdominal radiologists reviewed the CT and MR images for vascular and biliary variations. The strength of agreement between CT and MR angiography was assessed using the kappa index. The detection rate of biliary anatomical variations was calculated. The sensitivity and specificity for detecting significant steatosis (>5%) were calculated. The estimated total volume and right lobe volumes measured by MR volumetry were compared with the corresponding CT volumetry measurements using the intraclass correlation coefficient (ICC). Among the 35 patients, 26 underwent LT. The measurement of agreement showed a moderate to substantial agreement between CT and MR angiography interpretations (kappa values, 0.47-0.79; p < 0.001). Combining T2-weighted and T1-weighted MR cholangiography techniques detected all biliary anatomical variations in 9 of the 26 patients. MR-proton density fat fraction showed a sensitivity of 100% (3/3) and a specificity of 91.3% (21/23) for detecting pathologically determined steatosis (>5%). MR volumetry reached an excellent agreement with CT volumetry (reviewers 1 and 2: ICC, 0.92; 95% CI, 0.84-0.96). Our one-stop comprehensive liver donor MR imaging protocol can provide complete information regarding hepatic vascular and biliary anatomies, hepatic parenchymal quality, and liver volume for living liver donor candidates and can replace composite multimodality evaluation.
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Transplante de Fígado , Humanos , Transplante de Fígado/efeitos adversos , Meios de Contraste , Imageamento por Ressonância Magnética/métodos , Fígado/diagnóstico por imagem , Fígado/cirurgia , Fígado/irrigação sanguínea , Doadores VivosRESUMO
OBJECTIVES: Percutaneous radiofrequency ablation (RFA) is one of the curative treatments for hepatocellular carcinoma (HCC), but local tumor progression (LTP) has been a main limitation of RFA. This study aims to evaluate the LTP of percutaneous no-touch RFA (NtRFA) for HCC ≤ 5 cm and compare with conventional RFA (intratumoral puncture) through a systematic review and meta-analysis. METHODS: MEDLINE, EMBASE, and Cochrane Library were searched for studies on percutaneous NtRFA for HCC ≤ 5 cm. The pooled proportions of the overall and cumulative incidence rates at 1, 2, and 3 years for LTP after NtRFA were assessed using a random-effects model. For studies comparing NtRFA with conventional RFA, relative risks (RR) and hazard ratios (HR) were meta-analytically pooled with LTP as the outcome. RESULTS: Twelve studies with 900 patients were included. The pooled overall rate of LTP after NtRFA was 6% (95% CI, 4-8%). The pooled 1-, 2-, and 3-year cumulative incidence rates of LTP were 3% (95% CI, 2-5%), 5% (95% CI, 3- 9%), and 8% (95% CI, 6-11%), respectively. Compared to conventional RFA, the pooled RR and HR of LTP were 0.26 (95% CI, 0.16-0.41) and 0.28 (95% CI, 0.11-0.70), respectively (both p < 0.01). Subgroup analysis including only randomized controlled studies also showed better local tumor control of NtRFA with HR of 0.13 (95% CI, 0.14-0.42). CONCLUSIONS: Percutaneous NtRFA is an effective treatment for HCC ≤ 5 cm with an overall LTP rate of 6% and provides lower LTP compared with conventional RFA. KEY POINTS: ⢠The pooled 1-, 2-, and 3-year cumulative incidence rates of local tumor progression after no-touch radiofrequency ablation for HCC ≤ 5 cm were 3% (95% CI, 2-5%), 5% (95% CI, 3-9%), and 8% (95% CI, 6-11%). ⢠No-touch radiofrequency ablation had significantly lower rates of local tumor progression compared to conventional radiofrequency ablation (hazard ratio, 0.28; 95% CI, 0.11-0.70; relative risk, 0.26; 95% CI, 0.16-0.41; p < 0.01, respectively).
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Carcinoma Hepatocelular , Ablação por Cateter , Neoplasias Hepáticas , Ablação por Radiofrequência , Humanos , Carcinoma Hepatocelular/terapia , Neoplasias Hepáticas/patologia , Ablação por Cateter/efeitos adversos , Resultado do Tratamento , Recidiva Local de Neoplasia/cirurgia , Estudos RetrospectivosRESUMO
OBJECTIVE: Low monoenergetic images obtained using noise-reduction techniques may reduce CT contrast media requirements. We aimed to investigate the effectiveness of low-contrast-dose CT using dual-energy CT and deep learning-based denoising (DLD) techniques in patients at high risk of hepatocellular carcinoma (HCC). METHODS: We performed a prospective, randomized controlled noninferiority trial at a tertiary hospital between June 2019 and August 2020 (NCT04027556). Patients at high risk of HCC were randomly assigned (1:1) to the standard-contrast-dose group or low-contrast-dose group, which targeted a 40% reduction in contrast medium dose based on lean body weight. HCC conspicuity on arterial phase images was the primary endpoint with a noninferiority margin of 0.2. Images were independently assessed by three radiologists; model-based iterative reconstruction (MBIR) images of the standard-contrast-dose group and low monoenergetic (50-keV) DLD images of the low-contrast-dose group were compared using a generalized estimating equation. RESULTS: Ninety participants (age 59 ± 10 years; 68 men) were analyzed. Compared with the standard-contrast-dose group (n = 47), 40% less contrast media was used in the low-contrast-dose group (n = 43) (107.0 ± 17.1 mL vs. 64.5 ± 11.3 mL, p < 0.001). In the arterial phase, HCC conspicuity on 50-keV DLD images in the low-contrast-dose group was noninferior to that of MBIR images in the standard-contrast-dose group (2.92 vs. 2.56; difference, 0.36; 95% confidence interval, -0.13 to ∞; p = 0.013). CONCLUSIONS: The contrast dose in liver CT can be reduced by 40% without impairing HCC conspicuity when using 50-keV and DLD techniques. KEY POINTS: ⢠In the arterial phase, hepatocellular carcinoma conspicuity on 50-keV deep learning-based denoising images in the low-contrast-dose group was noninferior to that of model-based iterative reconstruction images in the standard-contrast-dose group. ⢠HCC detection was comparable between 50-keV deep learning-based denoising images in the low-contrast-dose group and model-based iterative reconstruction images in the standard-contrast-dose group.
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Carcinoma Hepatocelular , Aprendizado Profundo , Neoplasias Hepáticas , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Carcinoma Hepatocelular/diagnóstico por imagem , Neoplasias Hepáticas/diagnóstico por imagem , Meios de Contraste , Estudos Prospectivos , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Tomografia Computadorizada por Raios X/métodos , Razão Sinal-Ruído , Estudos Retrospectivos , AlgoritmosRESUMO
OBJECTIVES: To evaluate the recall rate and performance of free-breathing T1W dynamic imaging in patients who underwent gadoxetic acid-enhanced liver MRI. METHODS: We retrospectively reviewed patients who underwent free-breathing dynamic T1WI liver MRI using Cartesian (XD-VIBE) or self-gated radial (SG-GRASP) sequences at two institutions. Four radiologists independently reviewed the overall image quality, streak, and motion artifacts for precontrast, arterial, and portal venous phases on a 4-point scale. Hepatic observations were annotated and assessed according to LI-RADS v2018. RESULTS: In total, 360 patients were included (XD-VIBE [n = 253], SG-GRASP [n = 107]). The overall image quality of free-breathing T1WI was 3.4 ± 0.4, 3.2 ± 0.4, and 3.5 ± 0.4 for precontrast, arterial, and portal venous phases, respectively. The actual recall rate was 0.6% (2/360). The SG-GRASP group showed fewer motion artifacts and more streak artifacts than the XD-VIBE group in all phases (p < 0.001 for all). The overall image quality was not significantly different between the two sequences in arterial (3.2 ± 0.4 in both, p = 0.607) and portal venous phases (3.5 ± 0.4 in XD-VIBE, 3.4 ± 0.4 in SG-GRASP, p = 0.214). Two sequences did not show significant differences in the lesion detection rate (figure of merit, FOM: 0.67 vs. 0.68, p = 0.876) or diagnostic performance for hepatocellular carcinoma (FOM: 0.55 vs. 0.62, p = 0.105). CONCLUSIONS: Both XD-VIBE and SG-GRASP provided sufficient image quality for patients at risk of developing motion artifacts, without significant differences in image quality or the lesion detection rate between sequences. KEY POINTS: ⢠The overall image quality of free-breathing T1-weighted images using Cartesian or radial sequences was 3.4 ± 0.4, 3.2 ± 0.4, and 3.5 ± 0.4 for precontrast, arterial, and portal venous phases, respectively. ⢠Only 0.3% (1/360) had undiagnostic exams and the actual recall rate was 0.6% (2/360) in patients who underwent free-breathing dynamic T1WI. ⢠The overall lesion detection rate was 0.67 without a significant difference between Cartesian and radial sequences (figure of merit: 0.67 vs. 0.68, respectively, p = 0.876).
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Carcinoma Hepatocelular , Neoplasias Hepáticas , Humanos , Artefatos , Estudos Retrospectivos , Neoplasias Hepáticas/diagnóstico por imagem , Meios de Contraste/farmacologia , Imageamento por Ressonância Magnética/métodos , Aumento da Imagem/métodosRESUMO
OBJECTIVE: To investigate the image quality and lesion conspicuity of a deep-learning-based contrast-boosting (DL-CB) algorithm on double-low-dose (DLD) CT of simultaneous reduction of radiation and contrast doses in participants at high-risk for hepatocellular carcinoma (HCC). METHODS: Participants were recruited and underwent four-phase dynamic CT (NCT04722120). They were randomly assigned to either standard-dose (SD) or DLD protocol. All CT images were initially reconstructed using iterative reconstruction, and the images of the DLD protocol were further processed using the DL-CB algorithm (DLD-DL). The primary endpoint was the contrast-to-noise ratio (CNR), the secondary endpoint was qualitative image quality (noise, hepatic lesion, and vessel conspicuity), and the tertiary endpoint was lesion detection rate. The t-test or repeated measures analysis of variance was used for analysis. RESULTS: Sixty-eight participants with 57 focal liver lesions were enrolled (20 with HCC and 37 with benign findings). The DLD protocol had a 19.8% lower radiation dose (DLP, 855.1 ± 254.8 mGy·cm vs. 713.3 ± 94.6 mGy·cm, p = .003) and 27% lower contrast dose (106.9 ± 15.0 mL vs. 77.9 ± 9.4 mL, p < .001) than the SD protocol. The comparative analysis demonstrated that CNR (p < .001) and portal vein conspicuity (p = .002) were significantly higher in the DLD-DL than in the SD protocol. There was no significant difference in lesion detection rate for all lesions (82.7% vs. 73.3%, p = .140) and HCCs (75.7% vs. 70.4%, p = .644) between the SD protocol and DLD-DL. CONCLUSIONS: DL-CB on double-low-dose CT provided improved CNR of the aorta and portal vein without significant impairment of the detection rate of HCC compared to the standard-dose acquisition, even in participants at high risk for HCC. KEY POINTS: ⢠Deep-learning-based contrast-boosting algorithm on double-low-dose CT provided an improved contrast-to-noise ratio compared to standard-dose CT. ⢠The detection rate of focal liver lesions was not significantly differed between standard-dose CT and a deep-learning-based contrast-boosting algorithm on double-low-dose CT. ⢠Double-low-dose CT without a deep-learning algorithm presented lower CNR and worse image quality.
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Carcinoma Hepatocelular , Aprendizado Profundo , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/diagnóstico por imagem , Meios de Contraste , Neoplasias Hepáticas/diagnóstico por imagem , Estudos Prospectivos , Método Duplo-Cego , Doses de Radiação , Tomografia Computadorizada por Raios X/métodos , Algoritmos , Interpretação de Imagem Radiográfica Assistida por Computador/métodosRESUMO
OBJECTIVE: This prospective multicenter study aimed to evaluate the diagnostic performance of 80-kVp thin-section pancreatic CT in determining pancreatic ductal adenocarcinoma (PDAC) resectability according to the recent National Comprehensive Cancer Network (NCCN) guidelines. METHODS: We prospectively enrolled surgical resection candidates for PDAC from six tertiary referral hospitals (study identifier: NCT03895177). All participants underwent pancreatic CT using 80 kVp tube voltage with 1-mm reconstruction interval. The local resectability was prospectively evaluated using NCCN guidelines at each center and classified into three categories: resectable, borderline resectable, and unresectable. RESULTS: A total of 138 patients were enrolled; among them, 60 patients underwent neoadjuvant therapy. R0 resection was achieved in 103 patients (74.6%). The R0 resection rates were 88.7% (47/53), 52.4% (11/21), and 0.0% (0/4) for resectable, borderline resectable, and unresectable disease, respectively, in 78 patients who underwent upfront surgery. Meanwhile, the rates were 90.9% (20/22), 76.7% (23/30), and 25.0% (2/8) for resectable, borderline resectable, and unresectable PDAC, respectively, in patients who received neoadjuvant therapy. The area under curve of high-resolution CT in predicting R0 resection was 0.784, with sensitivity, specificity, and accuracy of 87.4% (90/103), 48.6% (17/35), and 77.5% (107/138), respectively. Tumor response was significantly associated with the R0 resection after neoadjuvant therapy (odds ratio [OR] = 38.99, p = 0.016). CONCLUSION: An 80-kVp thin-section pancreatic CT has excellent diagnostic performance in assessing PDAC resectability, enabling R0 resection rates of 88.7% and 90.9% for patients with resectable PDAC who underwent upfront surgery and patients with resectable PDAC after neoadjuvant therapy, respectively. KEY POINTS: ⢠The margin-negative (R0) resection rates were 88.7% (47/53), 52.4% (11/21), and 0.0% (0/4) for resectable, borderline resectable, and unresectable pancreatic ductal adenocarcinoma (PDAC), respectively, on 80-kVp thin-section pancreatic CT in the 78 patients who underwent upfront surgery. ⢠Among the 60 patients who underwent neoadjuvant therapy, the R0 rates were 90.9% (20/22), 76.7% (23/30), and 25.0% (2/8) for resectable, borderline resectable, and unresectable PDAC, respectively. ⢠Tumor response, along with the resectability status on pancreatic CT, was significantly associated with the R0 resection rate after neoadjuvant therapy.
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Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Humanos , Estudos Prospectivos , Neoplasias Pancreáticas/diagnóstico por imagem , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/patologia , Carcinoma Ductal Pancreático/diagnóstico por imagem , Carcinoma Ductal Pancreático/cirurgia , Carcinoma Ductal Pancreático/patologia , Tomografia Computadorizada por Raios X/métodos , Terapia Neoadjuvante , Neoplasias PancreáticasRESUMO
The 10th Global Forum for Liver Magnetic Resonance Imaging was held in October 2021. The themes of the presentations and discussions at this Forum are described in detail in the review by Taouli et al (2023). The focus of this second manuscript developed from the Forum is on multidisciplinary tumor board perspectives in hepatocellular carcinoma (HCC) management: how to approach early-, mid-, and late-stage management from the perspectives of a liver surgeon, an interventional radiologist, and an oncologist. The manuscript also includes a panel discussion by multidisciplinary experts on three selected cases that explore challenging aspects of HCC management. CLINICAL RELEVANCE STATEMENT: This review highlights the importance of a multidisciplinary team approach in liver cancer patients and includes the perspectives of a liver surgeon, an interventional radiologist, and an oncologist, including illustrative case studies. KEY POINTS: ⢠A liver surgeon, interventional radiologist, and oncologist presented their perspectives on the treatment of early-, mid-, and late-stage HCC. ⢠Different perspectives on HCC management between specialties emphasize the importance of multidisciplinary tumor boards. ⢠A multidisciplinary faculty discussed challenging aspects of HCC management, as highlighted by three case studies.
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Carcinoma Hepatocelular , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/terapia , Carcinoma Hepatocelular/patologia , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/patologia , Consenso , Meios de Contraste , Gadolínio DTPA , Imageamento por Ressonância Magnética/métodos , Espectroscopia de Ressonância Magnética , Equipe de Assistência ao PacienteRESUMO
The 10th Global Forum for Liver Magnetic Resonance Imaging (MRI) was held as a virtual 2-day meeting in October 2021, attended by delegates from North and South America, Asia, Australia, and Europe. Most delegates were radiologists with experience in liver MRI, with representation also from specialists in liver surgery, oncology, and hepatology. Presentations, discussions, and working groups at the Forum focused on the following themes: ⢠Gadoxetic acid in clinical practice: Eastern and Western perspectives on current uses and challenges in hepatocellular carcinoma (HCC) screening/surveillance, diagnosis, and management ⢠Economics and outcomes of HCC imaging ⢠Radiomics, artificial intelligence (AI) and deep learning (DL) applications of MRI in HCC. These themes are the subject of the current manuscript. A second manuscript discusses multidisciplinary tumor board perspectives: how to approach early-, mid-, and late-stage HCC management from the perspectives of a liver surgeon, interventional radiologist, and oncologist (Taouli et al, 2023). Delegates voted on consensus statements that were developed by working groups on these meeting themes. A consensus was considered to be reached if at least 80% of the voting delegates agreed on the statements. CLINICAL RELEVANCE STATEMENT: This review highlights the clinical applications of gadoxetic acid-enhanced MRI for liver cancer screening and diagnosis, as well as its cost-effectiveness and the applications of radiomics and AI in patients with liver cancer. KEY POINTS: ⢠Interpretation of gadoxetic acid-enhanced MRI differs slightly between Eastern and Western guidelines, reflecting different regional requirements for sensitivity vs specificity. ⢠Emerging data are encouraging for the cost-effectiveness of gadoxetic acid-enhanced MRI in HCC screening and diagnosis, but more studies are required. ⢠Radiomics and artificial intelligence are likely, in the future, to contribute to the detection, staging, assessment of treatment response and prediction of prognosis of HCC-reducing the burden on radiologists and other specialists and supporting timely and targeted treatment for patients.