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OBJECTIVES: Ultrasound is a safe and timely diagnosis method commonly used for breast lesion, however it depends on the operator to a certain degree. As an emerging technology, artificial intelligence can be combined with ultrasound in depth to improve the intelligence and precision of ultrasound diagnosis and avoid diagnostic errors caused by subjectivity of radiologists. This paper aims to investigate the value of artificial intelligence S-detect system combined with virtual touch imaging quantification (VTIQ) technique in the differential diagnosis of benign and malignant breast masses by conventional ultrasound (CUS). respectively, and AUCs for them were 0.74, 0.86, 0.79, and 0.94, respectively. The diagnostic accuracy of CUS+S-detect was higher than that of CUS (P<0.05). The diagnostic accuracy of CUS+S-detect was higher than that of CUS (P<0.05). The diagnostic specificity of CUS+VTIQ was higher than that of CUS (P<0.05). The diagnostic accuracy and AUC of CUS+S-detect+VTIQ were higher than those of S-detect or VTIQ applied to CUS alone (P<0.05). The sensitivities of CUS for senior radiologists, CUS for junior radiologists, CUS+S-detect+VTIQ for senior radiologists, and CUS+S-detect+VTIQ for junior radiologists were 60.00%, 80.00%, 72.73%, and 90.00%, respectively, when diagnosing benign and malignant breast masses in 50 randomly selected cases. The specificities for them was 66.67%, 76.67%, 80.00%, and 81.25%, respectively. The accuracies for them was 64.00%, 78.00%, 80.00%, and 88.00%, respectively. The AUCs for them were 0.63, 0.78, 0.88, and 0.80, respectively. Compared with the CUS for junior radiologists, the CUS+S-detect+VTIQ for junior radiologists had higher sensitivity, specificity, and accuracy (all P<0.05). The consistency of the combined application of S-detect and VTIQ for diagnosing breast masses at 2 different times was good among junior radiologists (Kappa=0.800). METHODS: CUS, S-detects, and VTIQ were used to differentially diagnose benign and malignant breast masses in 108 cases, and the final pathological results were referred to as the gold standard for classifying breast masses. The diagnostic efficacy were evaluated and compared, among the 3 methods and among S-detect applied to CUS (CUS+S-detect), VTIQ applied to CUS (CUS+VTIQ), and S-detect combined with VTIQ applied to CUS (CUS+S-detect+VTIQ). Fifty cases were acquired randomly from the collected breast masses, and 2 radiologists with different years of experience (2 and 8 years) used S-detect combined with VTIQ for the ultrasonic differential diagnosis of benign and malignant breast masses. RESULTS: The differences in sensitivity, specificity, accuracy, and the area under the receiver operating characteristic curve (AUC) of the 3 diagnostic methods of CUS, S-detect, and VTIQ were not statistically significant (all P>0.05). The sensitivities of CUS, CUS+Sdetect, CUS+VTIQ, and CUS+S-detect+VTIQ were 78.57%, 92.86%, 69.05%, and 95.24%, respectively, the specificities for them were 69.70%, 78.79%, 87.88%, and 92.42%, respectively, the accuracies for them were 73.15%, 84.26%, 80.56%, and 93.52%. CONCLUSIONS: S-detect combined with VTIQ when applied to CUS can overcome the shortcomings of separate applications and complement each other, especially for junior radiologists, and can more effectively improve the diagnostic efficacy of ultrasound for benign and malignant breast masses.
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Técnicas de Imagem por Elasticidade , Inteligência Artificial , Mama/diagnóstico por imagem , Diagnóstico Diferencial , Técnicas de Imagem por Elasticidade/métodos , Humanos , Ultrassonografia/métodosRESUMO
RATIONALE AND OBJECTIVES: S-Detect, a deep learning-based Computer-Aided Detection system, is recognized as an important tool for diagnosing breast lesions using ultrasound imaging. However, it may exhibit inconsistent findings across multiple imaging planes. This study aims to evaluate the diagnostic performance of S-Detect in different planes and identify factors contributing to these inconsistencies. MATERIALS AND METHODS: A retrospective cohort study was conducted on 711 patients with 756 breast lesions between January 2019 and January 2022. S-Detect was utilized to assess lesions in radial and anti-radial planes. BI-RADS classifications were employed for comparative analysis. The diagnostic performance was compared within each group, and p-values were computed for intergroup comparisons. Univariable and multivariable analyses were conducted to identify factors contributing to diagnostic inconsistency in S-Detect across planes. RESULTS: Among 756 breast lesions, 668 (88.4%) exhibited consistent S-Detect outcomes across planes while 88 (11.6%) were inconsistent. In the consistent group, the diagnostic accuracy and area under the curve (AUC) of S-Detect were significantly higher than those of BI-RADS (accuracy: 91.2% vs. 84.9%, p = 0.045; AUC: 0.916 vs. 0.859, p = 0.036). In the inconsistent group, the diagnostic accuracy and AUC of S-Detect in radial and anti-radial planes were lower than those of BI-RADS (accuracy: 47.7% for radial, 52.2% for anti-radial vs. 69.3% for BI-RADS, p = 0.014, p-anti = 0.039; AUC: 0.503 for radial, 0.497 for anti-radial vs. 0.739 for BI-RADS, p = 0.042, p-anti <0.001). Diagnostic inconsistency in S-Detect across planes was significantly associated with lesion size, indistinct or angular margins, and enhancement posterior acoustic features (p < 0.05). CONCLUSION: S-Detect has outperformed BI-RADS in diagnostic precision under conditions of inter-planar concordance. However, its diagnostic efficacy is compromised in scenarios of inter-planar discordance. Under these circumstances, the results of S-Detect should be carefully referenced.
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PURPOSE: A novel nomogram incorporating artificial intelligence (AI) and clinical features for enhanced ultrasound prediction of benign and malignant breast masses. MATERIALS AND METHODS: This study analyzed 340 breast masses identified through ultrasound in 308 patients. The masses were divided into training (n = 260) and validation (n = 80) groups. The AI-based analysis employed the Samsung Ultrasound AI system (S-detect). Univariate and multivariate analyses were conducted to construct nomograms using logistic regression. The AI-Nomogram was based solely on AI results, while the ClinAI- Nomogram incorporated additional clinical factors. Both nomograms underwent internal validation with 1000 bootstrap resamples and external validation using the independent validation group. Performance was evaluated by analyzing the area under the receiver operating characteristic (ROC) curve (AUC) and calibration curves. RESULTS: The ClinAI-Nomogram, which incorporates patient age, AI-based mass size, and AI-based diagnosis, outperformed an existing AI-Nomogram in differentiating benign from malignant breast masses. The ClinAI-Nomogram surpassed the AI-Nomogram in predicting malignancy with significantly higher AUC scores in both training (0.873, 95% CI: 0.830-0.917 vs. 0.792, 95% CI: 0.748-0.836; p = 0.016) and validation phases (0.847, 95% CI: 0.763-0.932 vs. 0.770, 95% CI: 0.709-0.833; p < 0.001). Calibration curves further revealed excellent agreement between the ClinAI-Nomogram's predicted probabilities and actual observed risks of malignancy. CONCLUSION: The ClinAI- Nomogram, combining AI alongside clinical data, significantly enhanced the differentiation of benign and malignant breast masses in clinical AI-facilitated ultrasound examinations.
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Inteligência Artificial , Neoplasias da Mama , Nomogramas , Ultrassonografia Mamária , Humanos , Neoplasias da Mama/diagnóstico por imagem , Feminino , Pessoa de Meia-Idade , Ultrassonografia Mamária/métodos , Adulto , Idoso , Mama/diagnóstico por imagem , Diagnóstico Diferencial , Reprodutibilidade dos Testes , Adulto JovemRESUMO
Background: The performance in evaluating thyroid nodules on ultrasound varies across different risk stratification systems, leading to inconsistency and uncertainty regarding diagnostic sensitivity, specificity, and accuracy. Objective: Comparing diagnostic performance of detecting thyroid cancer among distinct ultrasound risk stratification systems proposed in the last five years. Evidence acquisition: Systematic search was conducted on PubMed, EMBASE, and Web of Science databases to find relevant research up to December 8, 2022, whose study contents contained elucidation of diagnostic performance of any one of the above ultrasound risk stratification systems (European Thyroid Imaging Reporting and Data System[Eu-TIRADS]; American College of Radiology TIRADS [ACR TIRADS]; Chinese version of TIRADS [C-TIRADS]; Computer-aided diagnosis system based on deep learning [S-Detect]). Based on golden diagnostic standard in histopathology and cytology, single meta-analysis was performed to obtain the optimal cut-off value for each system, and then network meta-analysis was conducted on the best risk stratification category in each system. Evidence synthesis: This network meta-analysis included 88 studies with a total of 59,304 nodules. The most accurate risk category thresholds were TR5 for Eu-TIRADS, TR5 for ACR TIRADS, TR4b and above for C-TIRADS, and possible malignancy for S-Detect. At the best thresholds, sensitivity of these systems ranged from 68% to 82% and specificity ranged from 71% to 81%. It identified the highest sensitivity for C-TIRADS TR4b and the highest specificity for ACR TIRADS TR5. However, sensitivity for ACR TIRADS TR5 was the lowest. The diagnostic odds ratio (DOR) and area under curve (AUC) were ranked first in C-TIRADS. Conclusion: Among four ultrasound risk stratification options, this systemic review preliminarily proved that C-TIRADS possessed favorable diagnostic performance for thyroid nodules. Systematic review registration: https://www.crd.york.ac.uk/prospero, CRD42022382818.
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Neoplasias da Glândula Tireoide , Nódulo da Glândula Tireoide , Humanos , Nódulo da Glândula Tireoide/diagnóstico por imagem , Metanálise em Rede , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Área Sob a CurvaRESUMO
Background: S-detect is an emerging computer-aided diagnosis (CAD) technique that provides a reference for radiologists to identify breast cancer. Some studies have shown that US (ultrasound) + S-detect can improve the diagnostic accuracy of junior radiologists more than senior radiologists, but the results are inconsistent in various studies. Therefore, this meta-analysis aimed to assess the value of S-detect combined with the US outcomes from senior and junior radiologists for the diagnosis of breast cancer. Methods: We searched the PubMed, Cochrane Library, Embase, Web of Science, and Wanfang databases, China Biology Medicine disc, China National Knowledge Infrastructure (CNKI), and VIP database for trials on the diagnostic accuracy of US + S-detect for the diagnosis of breast masses. The search time frame was from the date of establishment of the database to August 20, 2022. Two researchers independently screened the literature, extracted the information, and evaluated the quality of the included literature using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) scale. StataSE 15.1 software was utilized to assess pooled metrics, including sensitivity, specificity, and the area under the curve (AUC). Results: A total of 19 articles with 3,349 patients and 3,895 breast masses were included in this meta-analysis. Of these, seventeen articles evaluated the diagnostic performance of senior radiologists' US + S-detect for breast cancer, while twelve articles reported junior radiologists' diagnostic performance. The risk of bias was primarily attributed to patient selection, flow and timing. In the senior radiologist group, the pooled sensitivity and specificity of US + S-detect were 0.93 [95% confidence interval (CI): 0.89-0.95] and 0.86 (95% CI: 0.80-0.90), respectively, with an AUC of 0.96. As for the junior radiologist group, the pooled sensitivity and specificity of US + S-detect were 0.89 (95% CI: 0.83-0.93) and 0.79 (95% CI: 0.72-0.84), respectively, and the AUC was 0.91. Conclusions: The results of this meta-analysis showed that the pooled sensitivity and the AUC of both the senior and junior radiologist groups were high, with good diagnostic efficacy and high clinical application. However, the results of this study are highly heterogeneous and need to be validated by collecting more high-quality studies and accumulating a larger sample size.
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OBJECTIVE: To evaluate the value of ultrasound S-Detect in the diagnosis of breast masses. METHODS: A total of 85 breast masses in 62 female patients were diagnosed by S-Detect technique and conventional ultrasound. The diagnostic efficacy of conventional ultrasound and S-Detect technique was analyzed and compared with postoperative pathological results as the gold standard. RESULTS: When operated by junior physicians, the diagnostic efficacy of conventional ultrasound was significantly lower than that of S-Detect technique (P < 0.05), but this difference was not observed in moderately experienced and senior physicians (P>0.05). S-Detect technique was positively correlated with the diagnostic results of senior physicians (r=0.97). Using S-Detect technique, the diagnostic efficacy did not differ significantly between the long axis section and its vertical section (P>0.05). Routine ultrasound showed a better diagnostic efficacy than S-Detect for breast masses with a diameter below 20 mm (P < 0.05), but for larger breast masses, its diagnostic efficacy was significantly lower than that of SDetect (P < 0.05). CONCLUSION: S-Detect can be used in differential diagnosis of benign and malignant breast masses, and its diagnostic efficiency can be comparable with that of BI-RADS classification for moderately experienced and senior physicians, but its diagnostic efficacy can be low for breast masses less than 20 mm in diameter.
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Neoplasias da Mama , Ultrassonografia Mamária , Mama/diagnóstico por imagem , Neoplasias da Mama/diagnóstico por imagem , Diagnóstico Diferencial , Feminino , Humanos , Sensibilidade e Especificidade , Ultrassom , Ultrassonografia , Ultrassonografia Mamária/métodosRESUMO
Background: S-Detect is a computer-assisted, artificial intelligence-based system of image analysis that has been integrated into the software of ultrasound (US) equipment and has the capacity to independently differentiate between benign and malignant focal breast lesions. Since the revision and upgrade in both the breast imaging-reporting and data system (BI-RADS) US lexicon and the S-Detect software in 2013, evidence that supports improved accuracy and specificity of radiologists' assessment of breast lesions has accumulated. However, such assessment using S-Detect technology to distinguish malignant from breast lesions with a diameter no greater than 2 cm requires further investigation. Methods: The US images of focal breast lesions from 295 patients in our hospital from January 2019 to June 2022 were collected. The BI-RADS data were evaluated by the embedded program and as manually modified prior to the determination of a pathological diagnosis. The receiver operator characteristic (ROC) curves were constructed to compare the diagnostic accuracy between the assessments of the conventional US images, the S-Detect classification, and the combination of the two. Results: There were 326 lesions identified in 295 patients, of which pathological confirmation demonstrated that 239 were benign and 87 were malignant. The sensitivity, specificity, and accuracy of the conventional imaging group were 75.86%, 93.31%, and 88.65%. The sensitivity, specificity, and accuracy of the S-Detect classification group were 87.36%, 88.28%, and 88.04%, respectively. The assessment of the amended combination of S-Detect with US image analysis (Co-Detect group) was improved with a sensitivity, specificity, and accuracy of 90.80%, 94.56%, and 93.56%, respectively. The diagnostic accuracy of the conventional US group, the S-Detect group, and the Co-Detect group using area under curves was 0.85, 0.88 and 0.93, respectively. The Co-Detect group had a better diagnostic efficiency compared with the conventional US group (Z = 3.882, p = 0.0001) and the S-Detect group (Z = 3.861, p = 0.0001). There was no significant difference in distinguishing benign from malignant small breast lesions when comparing conventional US and S-Detect techniques. Conclusions: The addition of S-Detect technology to conventional US imaging provided a novel and feasible method to differentiate benign from malignant small breast nodules.
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PURPOSE: To determine whether adding an artificial intelligence (AI) system to breast ultrasound (US) can reduce unnecessary biopsies. METHODS: Conventional US and AI analyses were prospectively performed on 173 suspicious breast lesions before US-guided core needle biopsy or vacuum-assisted excision. Conventional US images were retrospectively reviewed according to the BI-RADS 2013 lexicon and categories. Two downgrading stratifications based on AI assessments were manually used to downgrade the BI-RADS category 4A lesions to category 3. Stratification A was used to downgrade if the assessments of both orthogonal sections of a lesion from AI were possibly benign. Stratification B was used to downgrade if the assessment of any of the orthogonal sections was possibly benign. The effects of AI-based diagnosis on lesions to reduce unnecessary biopsy were analyzed using histopathological results as reference standards. RESULTS: Forty-three lesions diagnosed as BI-RADS category 4A by conventional US received AI-based hypothetical downgrading. While downgrading with stratification A, 14 biopsies were correctly avoided. The biopsy rate for BI-RADS category 4A lesions decreased from 100 % to 67.4 % (Pâ¯<⯠0.001). While downgrading with stratification B, 27 biopsies could be avoided with two malignancies missed, and the biopsy rate would decrease to 37.2 % (Pâ¯<⯠0.05, compared with conventional US and stratification A). CONCLUSION: Adding an AI system to breast US could reduce unnecessary lesion biopsies. Downgrading stratification A was recommended for its lower misdiagnosis rate.
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Inteligência Artificial , Neoplasias da Mama , Biópsia , Mama/diagnóstico por imagem , Neoplasias da Mama/diagnóstico por imagem , Feminino , Humanos , Estudos Retrospectivos , Ultrassonografia , Ultrassonografia MamáriaRESUMO
Objective Traditional breast ultrasound relies too much on the operation skills of diagnostic doctors, and the repeatability in different doctors was low. This study aimed to evaluate the assistant diagnostic value of S-Detect artificial intelligence (AI) system in differentiating benign from malignant breast masses. Methods The ultrasound images of 40 patients who underwent ultrasound examination in our hospital were collected. The conventional ultrasound images, elastic images, and S-Detect mode of breast lesions were analyzed. The breast imaging reporting and data system recommended by the American Society of Radiology (BI-RADS) classification for each breast mass was evaluated both by the doctor and AI. The receiver operator characteristics (ROC) curves were drawn to compare the diagnostic efficiency. Result Among the 40 lesions, 16 were benign, and 24 were malignant. The S-Detect AI system had a high diagnostic efficiency for malignant mass, with sensitivity, specificity, and accuracy of 95.8%, 93.8%, and 89.6%. The accuracy of AI was higher than the elastic image and then than the conventional gray-scale image. With the assistance of the S-Detect AI system, the accuracy of BI-RADS classification was improved significantly. Conclusion The S-Detect AI system will enhance breast cancer diagnostic accuracy and improve ultrasound examination quality.
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Neoplasias da Mama , Inteligência Artificial , Mama/diagnóstico por imagem , Neoplasias da Mama/diagnóstico por imagem , Diagnóstico Diferencial , Feminino , Humanos , Sensibilidade e Especificidade , Ultrassonografia MamáriaRESUMO
Computer-aided diagnosis (CAD) and other risk stratification systems may improve ultrasound image interpretation. This prospective study aimed to compare the diagnostic performance of CAD and the European Thyroid Imaging Reporting and Data System (EU-TIRADS) classification applied by physicians with S-Detect 2 software CAD based on Korean Thyroid Imaging Reporting and Data System (K-TIRADS) and combinations of both methods (MODELs 1 to 5). In all, 133 nodules from 88 patients referred to thyroidectomy with available histopathology or with unambiguous results of cytology were included. The S-Detect system, EU-TIRADS, and mixed MODELs 1-5 for the diagnosis of thyroid cancer showed a sensitivity of 89.4%, 90.9%, 84.9%, 95.5%, 93.9%, 78.9% and 93.9%; a specificity of 80.6%, 61.2%, 88.1%, 53.7%, 73.1%, 89.6% and 80.6%; a positive predictive value of 81.9%, 69.8%, 87.5%, 67%, 77.5%, 88.1% and 82.7%; a negative predictive value of 88.5%, 87.2%, 85.5%, 92.3%, 92.5%, 81.1% and 93.1%; and an accuracy of 85%, 75.9%, 86.5%, 74.4%, 83.5%, 84.2%, and 87.2%, respectively. Comparison showed superiority of the similar MODELs 1 and 5 over other mixed models as well as EU-TIRADS and S-Detect used alone (p-value < 0.05). S-Detect software is characterized with high sensitivity and good specificity, whereas EU-TIRADS has high sensitivity, but rather low specificity. The best diagnostic performance in malignant thyroid nodule (TN) risk stratification was obtained for the combined model of S-Detect ("possibly malignant" nodule) and simultaneously obtaining 4 or 5 points (MODEL 1) or exactly 5 points (MODEL 5) on the EU-TIRADS scale.
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PURPOSE: To assess the diagnostic performance and the potential as a teaching tool of S-detect in the assessment of focal breast lesions. METHODS: 61 patients (age 21-84 years) with benign breast lesions in follow-up or candidate to pathological sampling or with suspicious lesions candidate to biopsy were enrolled. The study was based on a prospective and on a retrospective phase. In the prospective phase, after completion of baseline US by an experienced breast radiologist and S-detect assessment, 5 operators with different experience and dedication to breast radiology performed elastographic exams. In the retrospective phase, the 5 operators performed a retrospective assessment and categorized lesions with BI-RADS 2013 lexicon. Integration of S-detect to in-training operators evaluations was performed by giving priority to S-detect analysis in case of disagreement. 2 × 2 contingency tables and ROC analysis were used to assess the diagnostic performances; inter-rater agreement was measured with Cohen's k; Bonferroni's test was used to compare performances. A significance threshold of p = 0.05 was adopted. RESULTS: All operators showed sensitivity > 90% and varying specificity (50-75%); S-detect showed sensitivity > 90 and 70.8% specificity, with inter-rater agreement ranging from moderate to good. Lower specificities were improved by the addition of S-detect. The addition of elastography did not lead to any improvement of the diagnostic performance. CONCLUSIONS: S-detect is a feasible tool for the characterization of breast lesions; it has a potential as a teaching tool for the less experienced operators.