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Development and Validation of the So-RADS: An Ultrasound-Based Risk Stratification System for Soft-Tissue Masses
Yanyan Wu1, Ting Cui1, Renjie Feng1
1Department of Ultrasound, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Ultrasound in Medicine & Biology
|May 17, 2026
Summary
The new soft-tissue radiology reporting and data system (So-RADS) standardizes ultrasound reporting for soft-tissue masses, improving diagnostic accuracy and providing clear management guidance for clinicians.
Area of Science:
- Radiology
- Medical Imaging
- Oncology
Background:
- Accurate diagnosis of soft-tissue masses (STMs) is challenging due to varied histology and lack of standardized ultrasound reporting.
- Subjective interpretation often leads to diagnostic uncertainty in STMs.
Purpose of the Study:
- To develop and validate the soft-tissue radiology reporting and data system (So-RADS) for ultrasound-based risk stratification of STMs.
- To address the limitations of subjective interpretation in STM diagnosis.
Main Methods:
- Retrospective study of 858 pathologically confirmed STMs.
- Model developed using 490 lesions with ambiguous ultrasound features.
- Multivariate logistic regression identified independent predictors of malignancy for scoring.
Main Results:
- Seven predictors (age, size, margin, shape, echogenicity, history, blood flow) formed the So-RADS score (0-10).
- So-RADS demonstrated excellent diagnostic performance (AUC=0.900) with high sensitivity (78.1%) and specificity (87.2%) at a cut-off score of ≥4.
- Substantial interobserver agreement (Kappa=0.784) was achieved.
Conclusions:
- The So-RADS system is a robust and reproducible tool for standardizing STM ultrasound reporting.
- It improves diagnostic accuracy and provides clear management recommendations.
- So-RADS facilitates consistent risk stratification for STMs.
