Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast … (NCT06993246) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?
Canada50 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
50 Years – 69 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection Rate of Breast Cancer
Timeframe: Three years from the study start date.
Trial details
NCT IDNCT06993246
SponsorJean Seely
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-09-30
Contact for this trial
Dr. Jean Seely Department of Radiology, Radiation Oncology, MD, FRCPC, MD, FRCPC