NCT06993246

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

Does Supplemental Contrast-enhanced Mammography Have a Benefit in Women With a Personal History of Breast Cancer and Dense Breast Tissue? A Prospective Cohort Study.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Jean Seely · Academic / Other
• Sex: Female
• Age: 50 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Outcome Measure: 1. Detection Rate of Breast Cancer The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-09-30
• Completion: 2028-09-30
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: Canada