Diagnostic Performance of Contrast-Enhanced Mammography

Not yet recruiting

• Conditions: Mammography

• Registration Number: NCT06713915
• Lead Sponsor: ZHOU Yidong

Brief Summary

Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.

This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Study Start: 2025-01
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above;
• Willing to undergo enhanced mammography examination;
• Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.

Exclusion Criteria

• Allergy to iodinated contrast;
• Pregnant and lactating women;
• Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis;
• The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lesion biopsy rate	2 years	Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM.
breast cancer detection rate	2 years	Proportion of breast cancer detected among all patients undergoing biopsy.

Secondary Outcome Measures

Name	Time	Method
number of BI-RADS score upgrade	3 years	number of BI-RADS score upgrade during follow-up

Trial Locations

Locations (1)

Department of Breast Surgery,Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China