Diagnostic Performance of Contrast-Enhanced Mammography

NCT06713915 | Not Yet Recruiting FDA Device

• 1 other identifier: PUMCH-breast-CEM
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammography

Keywords

breast cancer; breast ultrasound; contrast enhanced mammography

Outcome Measures

Primary Outcomes (2)

• lesion biopsy rate

  Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM.

  2 years

• breast cancer detection rate

  Proportion of breast cancer detected among all patients undergoing biopsy.

  2 years

Secondary Outcomes (1)

• number of BI-RADS score upgrade

  3 years

Study Arms (2)

prospective cohort

Women with suspected breast abnormalities in prospective cohort will be prospectively evaluated with CEM, including acquisition of low-energy (LE) images and reconstructed images (RI) showing enhancement, concurrently with breast ultrasound (US) evaluation.

Diagnostic Test: Contrast-Enhanced Mammography

retrospective cohort

The retrospective cohort will select the mammography and breast US data (BI-RADS score) of female patients with suspected breast abnormalities who had previous baseline matching.

Interventions

Contrast-Enhanced Mammography DIAGNOSTIC_TEST

Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound.

prospective cohort

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast lesions BI-RADS 4 and above treated at the Breast Surgery Department of Peking Union Medical College Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZHOU Yidong: lead

Study Sites (1)

Department of Breast Surgery,Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yanna Zhang, M.D

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Yidong Zhou, Master

CONTACT

+86-10-69158720; zhouyd@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Breast Surgery Director

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)