About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Patients with renal insufficiency (reduced eGFR <20ml/min)
Previous allergic reactions to Iodine-based contrast.
Prior contrast allergy (CT contrast)
Thyroid Disease
Trial design
Treatments tested in this trial
- Contrast-Enhanced Mammography (CEM)
Treatment groups
Sponsors and collaborators
Jean Seely
Lead sponsor
Ottawa Hospital Research Institute
Sponsor institution
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Collaborator