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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06993246
• Lead Sponsor: Jean Seely

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Study Start: 2025-09-15
• Primary Completion: 2026-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women presenting at Rose Ages Breast Health Center, who are currently waiting for supplemental screening Ultrasound, according to pre-established guidelines at TOH for supplemental screening.
• Women ages 50-69 years of age
• Those willing to participate in the study, sign an informed consent and undergo IV iodinated contrast injection
• Women with dense breasts (category C or D) and normal mammograms (BI-RADS 1 or 2)
• No evidence of renal disease

Exclusion Criteria

• Patients with renal insufficiency (reduced eGFR <20ml/min)
• Previous allergic reactions to Iodine-based contrast.
• Prior contrast allergy (CT contrast)
• Thyroid Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Detection Rate of Breast Cancer	Three years from the study start date.	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.

Secondary Outcome Measures

Name	Time	Method
Lesion Characterization	Up to one year.	Assessment of the ability of CEM to accurately characterize breast lesions in terms of malignancy (benign or malignant). This will be evaluated by comparing CEM findings with biopsy results.
Patient Experience	Immediate post-procedure.	A patient-reported survey measuring comfort, satisfaction, and perceived usefulness of CEM compared to traditional mammography.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada