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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-69
SponsorJean Seely

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

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jean Seely

Lead sponsor

Ottawa Hospital Research Institute

Sponsor institution

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Collaborator