Status:
NOT_YET_RECRUITING
Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?
Lead Sponsor:
Jean Seely
Collaborating Sponsors:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-69 years
Phase:
NA
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 his...
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 (CE...
Eligibility Criteria
Inclusion
- 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
- Patients with renal insufficiency (reduced eGFR \<20ml/min)
- Previous allergic reactions to Iodine-based contrast.
- Prior contrast allergy (CT contrast)
- Thyroid Disease
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06993246
Start Date
September 15 2025
End Date
September 30 2028
Last Update
May 28 2025
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 9L6