Objective:

To evaluate the diagnostic accuracy, reproducibility, and clinical utility of SWE for differentiating benign and malignant soft-tissue tumors.

Approach:

• Study Selection: Eligible studies included patients with histologically verified extraosseous soft-tissue masses evaluated using quantitative SWE.
• Data Extraction: Sensitivity, specificity, and area under the ROC curve (AUC) were extracted or reconstructed.
• Synthesis Method: Due to methodological and threshold heterogeneity, a narrative synthesis was performed.
• Evidence Rating: Certainty of evidence was rated with GRADE-DTA.

Key Findings:

• Ten studies (n = 1,335 lesions; 22-41% malignant) met inclusion criteria.
• SWE reproducibility was high (intraclass correlation coefficient > 0.85 in four studies).
• Diagnostic performance varied widely (AUC range 0.57-0.87).
• SWE showed higher specificity in benign-appearing or superficial lesions but struggled to distinguish lipomatous or deep lesions from malignancy.
• MRI was superior in most direct comparisons (AUC 0.85-0.90).
• Certainty of evidence was moderate for superficial lesions and low for deep or lipomatous tumors.

Interpretation:

SWE demonstrates excellent reproducibility but inconsistent diagnostic utility across lesion types.

Limitations:

• Marked methodological and threshold heterogeneity.
• Poor cross-vendor reproducibility.
• Limited generalizability due to varying lesion characteristics.

Conclusion:

Standardized acquisition protocols and vendor calibration are prerequisites for broader clinical adoption.

Sources:

• Systematic Review Registration