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Evaluation of diagnostic value of shear wave elastography in breast BI-RADS category 4 lesions

Evaluation of diagnostic value of shear wave elastography in breast BI-RADS category 4 lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113567
Enrollment
Unknown
Registered
2025-12-01
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BI-RADS4 breast nodules

Interventions

Gold Standard:Coarse needle aspiration biopsy or intraoperative specimen biopsy
Index test:Shear Wave Elastography (SWE)

Sponsors

China Aerospace Science & Industry Corporation 731 Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients whose diagnoses meet the BI-RADS 4 category standards issued by the American College of Radiology

Exclusion criteria

Exclusion criteria: 1. Age < 18 years old; 2. Patients who have undergone breast biopsy, surgery, radiotherapy or chemotherapy within the past 6 months; 3. Individuals with poor image quality or unable to complete shear wave elastography examination; 4. Lesions with multiple lesions, tumor fusion or unclear boundaries making it difficult to define the ROI (Region of Interest) area are excluded.

Design outcomes

Primary

MeasureTime frame
Diagnostic efficacy of shear wave elastography;

Secondary

MeasureTime frame
Best diagnostic threshold and diagnostic indicators;Inter group differences in SWE parameters;The effectiveness of the joint diagnostic model;

Countries

China

Contacts

Public ContactYan Jiang

China Aerospace Science & Industry Corporation 731 Hospital

82844998@qq.com+86 10 56373086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026