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Background Comparative performance between artificial intelligence (AI) and breast US for women with dense breasts undergoing screening mammography remains unclear. Purpose To compare the performance of mammography alone, mammography with AI, and mammography plus supplemental US for screening women with dense breasts, and to investigate the characteristics of the detected cancers. Materials and Methods A retrospective database search identified consecutive asymptomatic women (≥40 years of age) with dense breasts who underwent mammography plus supplemental whole-breast handheld US from January 2017 to December 2018 at a primary health care center. Sequential reading for mammography alone and mammography with the aid of an AI system was conducted by five breast radiologists, and their recall decisions were recorded. Results of the combined mammography and US examinations were collected from the database. A dedicated breast radiologist reviewed marks for mammography alone or with AI to confirm lesion identification. The reference standard was histologic examination and 1-year follow-up data. The cancer detection rate (CDR) per 1000 screening examinations, sensitivity, specificity, and abnormal interpretation rate (AIR) of mammography alone, mammography with AI, and mammography plus US were compared. Results Among 5707 asymptomatic women (mean age, 52.4 years ± 7.9 [SD]), 33 (0.6%) had cancer (median lesion size, 0.7 cm). Mammography with AI had a higher specificity (95.3% [95% CI: 94.7, 95.8], P = .003) and lower AIR (5.0% [95% CI: 4.5, 5.6], P = .004) than mammography alone (94.3% [95% CI: 93.6, 94.8] and 6.0% [95% CI: 5.4, 6.7], respectively). Mammography plus US had a higher CDR (5.6 vs 3.5 per 1000 examinations, P = .002) and sensitivity (97.0% vs 60.6%, P = .002) but lower specificity (77.6% vs 95.3%, P < .001) and higher AIR (22.9% vs 5.0%, P < .001) than mammography with AI. Supplemental US alone helped detect 12 cancers, mostly stage 0 and I (92%, 11 of 12). Conclusion Although AI improved the specificity of mammography interpretation, mammography plus supplemental US helped detect more node-negative early breast cancers that were undetected using mammography with AI. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Whitman and Destounis in this issue.
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Inteligência Artificial , Densidade da Mama , Neoplasias da Mama , Detecção Precoce de Câncer , Mamografia , Ultrassonografia Mamária , Humanos , Feminino , Mamografia/métodos , Neoplasias da Mama/diagnóstico por imagem , Pessoa de Meia-Idade , Estudos Retrospectivos , Ultrassonografia Mamária/métodos , Detecção Precoce de Câncer/métodos , Adulto , Sensibilidade e Especificidade , Mama/diagnóstico por imagem , IdosoRESUMO
BACKGROUND: Optic neuritis (ON) prognosis is influenced by various factors including attack severity, underlying aetiologies, treatments and consequences of previous episodes. This study, conducted on a large cohort of first ON episodes, aimed to identify unique prognostic factors for each ON subtype, while excluding any potential influence from pre-existing sequelae. METHODS: Patients experiencing their first ON episodes, with complete aquaporin-4 (AQP4) and myelin oligodendrocyte glycoprotein (MOG) antibody testing, and clinical data for applying multiple sclerosis (MS) diagnostic criteria, were enrolled. 427 eyes from 355 patients from 10 hospitals were categorised into four subgroups: neuromyelitis optica with AQP4 IgG (NMOSD-ON), MOG antibody-associated disease (MOGAD-ON), ON in MS (MS-ON) or idiopathic ON (ION). Prognostic factors linked to complete recovery (regaining 20/20 visual acuity (VA)) or moderate recovery (regaining 20/40 VA) were assessed through multivariable Cox regression analysis. RESULTS: VA at nadir emerged as a robust prognostic factor for both complete and moderate recovery, spanning all ON subtypes. Early intravenous methylprednisolone (IVMP) was associated with enhanced complete recovery in NMOSD-ON and MOGAD-ON, but not in MS-ON or ION. Interestingly, in NMOSD-ON, even a slight IVMP delay in IVMP by >3 days had a significant negative impact, whereas a moderate delay up to 7-9 days was permissible in MOGAD-ON. Female sex predicted poor recovery in MOGAD-ON, while older age hindered moderate recovery in NMOSD-ON and ION. CONCLUSION: This comprehensive multicentre analysis on first-onset ON unveils subtype-specific prognostic factors. These insights will assist tailored treatment strategies and patient counselling for ON.
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Autoanticorpos , Metilprednisolona , Glicoproteína Mielina-Oligodendrócito , Neurite Óptica , Humanos , Masculino , Feminino , Prognóstico , Adulto , Neurite Óptica/diagnóstico , Neurite Óptica/imunologia , Glicoproteína Mielina-Oligodendrócito/imunologia , Pessoa de Meia-Idade , Autoanticorpos/sangue , Metilprednisolona/uso terapêutico , Neuromielite Óptica/diagnóstico , Neuromielite Óptica/imunologia , Aquaporina 4/imunologia , Acuidade Visual/fisiologia , Esclerose Múltipla/diagnóstico , Esclerose Múltipla/imunologia , Adulto Jovem , Adolescente , IdosoRESUMO
BACKGROUND: ArtiSential, a new articulating laparoscopic instruments, addresses the limited movement associated with conventional laparoscopic instruments. This study was conducted to assess the clinical effectiveness of ArtiSential in detailed steps of various renal surgery. METHODS: This study was approved by the Institutional Review Board of our institution and registered on the Clinical Research Information Service site of the Korea Disease Control and Prevention Agency. Participants meeting all inclusion and exclusion criteria were included in the clinical trial and underwent renal surgery. The clinical effectiveness of ArtiSential was assessed in terms of the feasibility and objective and subjective parameters across 9 detailed steps. RESULTS: Of the 15 potential candidates enrolled from October 2021 to November 2021, 1 patient dropped out due to anaphylaxis from an anesthetic agent, and 14 patients underwent laparoscopic surgery using ArtiSential. Of the 14 patients, 2 patients were converted to laparoscopic surgery using straight-shaped instruments due to the ischemia time exceeding 30 min, and 1 patient due to excessive bleeding. The feasibility for most steps was more than 90%, except the renorrhaphy step. The median total operation time and ischemia time were 161 and 23 min, respectively. The median estimated blood loss was 58.5 mL. Two cases of venous injury occurred during renal pedicle dissection step. The accuracy of the procedure judged by reviewers and usability judged by the operator were acceptable in all steps. The surgeon's quantitatively measured stress score was the highest during renorrhaphy step. CONCLUSIONS: Laparoscopic surgery using ArtiSential is feasible for most steps except the renorrhaphy step. The difficulty of performing renorrhaphy is attributed to prolonged ischemia time, which could be addressed by overcoming the learning curve. TRIAL REGISTRATION: Clinical Research Information Service site of the Korea Disease Control and Prevention Agency, KCT0006532. Registered 03/09/2021, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24071 .
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Laparoscopia , Humanos , Masculino , Feminino , Laparoscopia/métodos , Pessoa de Meia-Idade , Idoso , Adulto , Estudos de Viabilidade , Desenho de Equipamento , Rim/cirurgia , Nefrectomia/métodosAssuntos
Carcinoma Hepatocelular , Hepatectomia , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/cirurgia , Carcinoma Hepatocelular/radioterapia , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/patologia , Neoplasias Hepáticas/cirurgia , Neoplasias Hepáticas/patologia , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/radioterapia , Resultado do Tratamento , Carga Tumoral , Fatores de Tempo , Radioterapia AdjuvanteRESUMO
PURPOSE: This study aims to test the hypothesis that idarubicin-based transarterial chemoembolization (IDA-TACE), using one of the most potent chemotherapeutic agents, could yield oncologic outcomes equivalent to or marginally improved over doxorubicin-based TACE (DOX-TACE). MATERIALS AND METHODS: This single-center, prospective, phase II, randomized controlled, non-inferiority, double-blind trial will enroll 128 treatment-naïve patients with HCC (≤ 5 tumors, 1-5 cm in diameter) for conventional TACE. Participants will be randomly assigned (1:1) to either IDA-TACE or DOX-TACE, with stratification by Child-Pugh class. Superselective conventional TACE will be performed using cone-beam CT and small-bore microcatheters. Patient evaluations, including dynamic imaging and blood tests, will occur at 1, 3, and 6 months post-initial treatment. The primary outcome measure is the objective response rate (ORR) according to mRECIST at 6 months. Secondary outcomes include 3-month and 6-month tumor responses, time-to-progression, the incidence of treatment-related serious adverse events within 30 days, and the incidence and severity of any adverse events. STATISTICS: Non-inferiority will be claimed if the upper limit of a one-sided 97.5% confidence interval for the proportion difference (i.e., "6-month ORR of DOX-TACE" - "6-month ORR of IDA-TACE") falls below 0.15 in both intention-to-treat and per-protocol analyses. The proportion difference and its confidence interval will be calculated by the Cochran-Mantel-Haenszel method to obtain a weighted average of stratum-specific proportion differences. EXPECTED GAIN OF KNOWLEDGE: If IDA-TACE demonstrates outcomes comparable to DOX-TACE, this study could provide compelling evidence that various cytotoxic agents yield similar contributions in TACE, considering the minor role of chemotherapeutic agents in TACE. TRIAL REGISTRATION: ClinicalTrials.gov ( https://clinicaltrials.gov/ ). Identifier: NCT06114082. World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) ( https://trialsearch.who.int/Default.aspx ). Identifier: KCT0008166.
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Carcinoma Hepatocelular , Quimioembolização Terapêutica , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/terapia , Carcinoma Hepatocelular/tratamento farmacológico , Quimioembolização Terapêutica/métodos , Ensaios Clínicos Fase II como Assunto , Doxorrubicina/uso terapêutico , Idarubicina/uso terapêutico , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/tratamento farmacológico , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Estudos de Equivalência como AsuntoRESUMO
RATIONALE AND OBJECTIVES: Little is known about the factors affecting the Artificial Intelligence (AI) software performance on mammography for breast cancer detection. This study was to identify factors associated with abnormality scores assigned by the AI software. MATERIALS AND METHODS: A retrospective database search was conducted to identify consecutive asymptomatic women who underwent breast cancer surgery between April 2016 and December 2019. A commercially available AI software (Lunit INSIGHT, MMG, Ver. 1.1.4.0) was used for preoperative mammography to assign individual abnormality scores to the lesions and score of 10 or higher was considered as positive detection by AI software. Radiologists without knowledge of the AI results retrospectively assessed the mammographic density and classified mammographic findings into positive and negative finding. General linear model (GLM) analysis was used to identify the clinical, pathological, and mammographic findings related to the abnormality scores, obtaining coefficient ß values that represent the mean difference per unit or comparison with the reference value. Additionally, the reasons for non-detection by the AI software were investigated. RESULTS: Among the 1001 index cancers (830 invasive cancers and 171 ductal carcinoma in situs) in 1001 patients, 717 (72%) were correctly detected by AI, while the remaining 284 (28%) were not detected. Multivariable GLM analysis showed that abnormal mammography findings (ß = 77.0 for mass, ß = 73.1 for calcification only, ß = 49.4 for architectural distortion, and ß = 47.6 for asymmetry compared to negative; all Ps < 0.001), invasive tumor size (ß = 4.3 per 1 cm, P < 0.001), and human epidermal growth receptor type 2 (HER2) positivity (ß = 9.2 compared to hormone receptor positive, HER2 negative, P = 0.004) were associated with higher mean abnormality score. AI failed to detect small asymmetries in extremely dense breasts, subcentimeter-sized or isodense lesions, and faint amorphous calcifications. CONCLUSION: Cancers with positive abnormal mammographic findings on retrospective review, large invasive size, HER2 positivity had high AI abnormality scores. Understanding the patterns of AI software performance is crucial for effectively integrating AI into clinical practice.
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Inteligência Artificial , Neoplasias da Mama , Mamografia , Humanos , Feminino , Neoplasias da Mama/diagnóstico por imagem , Mamografia/métodos , Estudos Retrospectivos , Pessoa de Meia-Idade , Adulto , Idoso , Software , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Densidade da MamaRESUMO
Purpose To investigate quantitative CT (QCT) measurement variability in interstitial lung disease (ILD) on the basis of two same-day CT scans. Materials and Methods Participants with ILD were enrolled in this multicenter prospective study between March and October 2022. Participants underwent two same-day CT scans at an interval of a few minutes. Deep learning-based texture analysis software was used to segment ILD features. Fibrosis extent was defined as the sum of reticular opacity and honeycombing cysts. Measurement variability between scans was assessed with Bland-Altman analyses for absolute and relative differences with 95% limits of agreement (LOA). The contribution of fibrosis extent to variability was analyzed using a multivariable linear mixed-effects model while adjusting for lung volume. Eight readers assessed ILD fibrosis stability with and without QCT information for 30 randomly selected samples. Results Sixty-five participants were enrolled in this study (mean age, 68.7 years ± 10 [SD]; 47 [72%] men, 18 [28%] women). Between two same-day CT scans, the 95% LOA for the mean absolute and relative differences of quantitative fibrosis extent were -0.9% to 1.0% and -14.8% to 16.1%, respectively. However, these variabilities increased to 95% LOA of -11.3% to 3.9% and -123.1% to 18.4% between CT scans with different reconstruction parameters. Multivariable analysis showed that absolute differences were not associated with the baseline extent of fibrosis (P = .09), but the relative differences were negatively associated (ß = -0.252, P < .001). The QCT results increased readers' specificity in interpreting ILD fibrosis stability (91.7% vs 94.6%, P = .02). Conclusion The absolute QCT measurement variability of fibrosis extent in ILD was 1% in same-day CT scans. Keywords: CT, CT-Quantitative, Thorax, Lung, Lung Diseases, Interstitial, Pulmonary Fibrosis, Diagnosis, Computer Assisted, Diagnostic Imaging Supplemental material is available for this article. © RSNA, 2024.
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Doenças Pulmonares Intersticiais , Fibrose Pulmonar , Idoso , Feminino , Humanos , Masculino , Modelos Lineares , Doenças Pulmonares Intersticiais/diagnóstico , Estudos Prospectivos , Tomografia Computadorizada por Raios X , Pessoa de Meia-IdadeRESUMO
CONTEXT: With advancements in long-term survival after pancreatectomy, post-pancreatectomy diabetes has become a concern, and the risk factors are not established yet. Pancreatic islets are susceptible to ischemic damage, though there is a lack of clinical evidence regarding glycemic deterioration. OBJECTIVE: To investigate association between hypotension during pancreatectomy and development of post-pancreatectomy diabetes. DESIGN: In this retrospective, longitudinal cohort study, we enrolled patients without diabetes who underwent distal pancreatectomy or pancreaticoduodenectomy between January 2005 and December 2018, from two referral hospitals in Korea. MAIN OUTCOME MEASURES: Intraoperative hypotension [IOH] was defined as a 20% or greater reduction in systolic blood-pressure. The primary and secondary outcomes were incident diabetes and postoperative Homeostatic Model Assessment [HOMA] indices. RESULTS: We enrolled 1,129 patients (average age, 59 years; 49% men; 35% distal pancreatectomy). IOH occurred in 83% (median duration, 25 minutes; interquartile range [IQR], 5-65). During a median follow-up of 3.9 years, diabetes developed in 284 patients (25%). The cumulative incidence of diabetes was proportional to increases in the duration and depth of IOH (P < 0.001). For the median duration in an IOH when compared to a reference time of 0 minute, the hazard ratio [HR] was 1.48 (95% CI, 1.14-1.92). The effect was pronounced with distal pancreatectomy compared to pancreaticoduodenectomy. Furthermore, the duration of IOH was inversely correlated with 1-year HOMA beta-cell function (P < 0.002), but not with HOMA insulin resistance. CONCLUSIONS: These results support the hypothesis that IOH during pancreatectomy may elevate risk of diabetes by inducing beta cell insufficiency.