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Stratified risk assessment of BI-RADS 4 lesions at sub-centimeter level by ultrasound

Stratified risk assessment of BI-RADS 4 lesions at sub-centimeter level by ultrasound

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096843
Enrollment
Unknown
Registered
2025-02-07
Start date
2024-05-29
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Sub-centimeter BI-RADS 4 breast lesions

Interventions

Gold Standard:pathology
Index test:Multimodal ultrasound.

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Not in pregnancy; 2.There was no history of radiotherapy and chemotherapy for breast cancer; 3.There was no contraindication to the use of ultrasound contrast agents; 4.Be able to provide informed consent and be willing to comply with the requirements of the study protocol and provide complete clinical and imaging data; 5.Gold standard results (biopsy or surgical pathology);

Exclusion criteria

Exclusion criteria: 1.Pregnant women; 2.The breast had been treated with chemoradiotherapy; 3.Contrast-enhanced ultrasound was contraindicated; 4.Clinical or imaging data were incomplete; 5.The investigator determined the presence of any medical or other condition that would seriously reduce the likelihood of obtaining reliable data, meeting the study objectives, or completing the study and subsequent follow-up examinations.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;ROC curve;

Countries

China

Contacts

Public ContactLu Chunyu

Shengjing Hospital of China Medical University

18642733104@139.com+86 18940253848

Outcome results

None listed

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