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Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?

NCT06993246 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-28

No results posted yet for this study

Summary

This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. CEM combines standard mammography with a contrast agent to better detect tumors, particularly in women with dense tissue where traditional mammograms may miss signs of cancer. The study will compare CEM with ultrasound and MRI to determine its accuracy in detecting cancer, reduce wait times for screening, and provide a more affordable option than MRI. Women who participate will have their screening done in one visit, improving convenience and access. The study will track cancer detection rates, biopsy results, and patient satisfaction over two years to evaluate the benefits of CEM for early breast cancer detection.

Conditions

Interventions

DIAGNOSTIC_TEST

Contrast-Enhanced Mammography (CEM)

The intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effective alternative to MRI, with comparable sensitivity in detecting breast cancer. Participants will undergo the CEM procedure in a single visit, allowing for reduced wait times and improved detection rates compared to traditional methods. The procedure is well-tolerated, with minimal side effects, and provides a quicker and more accessible option for supplemental breast cancer screening.

Sponsors & Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • Jean Seely

    lead OTHER

Principal Investigators

  • Dr. Jean Seely Principal Investigator,, MD FRCPC · Ottawa Hospital Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-09-30
Completion
2028-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993246 on ClinicalTrials.gov