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Study identifier: NCT07500428 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models

Condition: Breast Neoplasms · Breast Diseases · Ultrasonography  ·  Sponsor: Peking Union Medical College Hospital

PhaseN/A
Planned participants1380
Who can joinFemale, 18 Years to 75 Years
Healthy volunteersYes

About this study

This single-center, retrospective, observational study aims to construct a standardized benchmark evaluation system for intelligent breast ultrasound image interpretation and to systematically assess the diagnostic performance of current mainstream multimodal artificial intelligence (AI) models. De-identified B-mode breast ultrasound images with confirmed pathological diagnoses will be retrospectively collected from the institutional archive (2018-2025) and supplemented with images from published open-access datasets. Expert radiologists with varying experience levels will independently annotate all images according to the American College of Radiology (ACR) Breast Imaging Reporting and Data System (BI-RADS) v2025 criteria, including glandular tissue composition, lesion characterization (mass vs. non-mass lesion), morphological descriptors, and final BI-RADS classification. Baseline deep learning models (CNN-based ResNet-50 and Transformer-based USFM) will be trained to establish performance baselines and to stratify cases by diagnostic difficulty through cross-architecture consensus. Multiple multimodal large language models (MLLMs), including both general-purpose and medical-domain models, will then be evaluated via standardized API calls using BI-RADS-guided chain-of-thought prompts at temperature 0 for reproducibility. Primary endpoints include BI-RADS classification accuracy and diagnostic AUC for benign-malignant differentiation. Model robustness and safety will be a…

This description comes directly from the study's public registry record.

Talk to the study team

Qingli Zhu, MD  ·  +86 13621376699  ·  zqlpumch@126.com

Yinglan Wu, MD  ·  +86 15626121076  ·  wuylan7@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Peking Union Medical College HospitalBeijing, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07500428