Diagnostic Performance of Contrast-Enhanced Mammography

November 27, 2024 updated by: ZHOU Yidong

Diagnostic Performance of Contrast-Enhanced Mammography in Suspicious Breast Lesions

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yidong Zhou, Master
  • Phone Number: +86-10-69158720
  • Email: zhouyd@pumch.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Department of Breast Surgery,Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yidong Zhou, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lesion biopsy rate
Time Frame: 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.
2 years
breast cancer detection rate
Time Frame: 2 years
Proportion of breast cancer detected among all patients undergoing biopsy.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of BI-RADS score upgrade
Time Frame: 3 years
number of BI-RADS score upgrade during follow-up
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZHOU Yidong

Investigators

  • Study Chair: Yanna Zhang, M.D, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PUMCH-breast-CEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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