Status:
COMPLETED
Screening Contrast-Enhanced Mammography as an Alternative to MRI
Lead Sponsor:
Wendie Berg
Collaborating Sponsors:
PA Breast Cancer Coalition
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-75 years
Phase:
PHASE4
Brief Summary
There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, ot...
Detailed Description
This is a prospective study designed to evaluate the role of contrast enhanced mammography (CEM) in screening for breast cancer. The overarching goal of the research program is to improve cancer detec...
Eligibility Criteria
Inclusion
- Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria:
- Women known to be at high risk for breast cancer because of known or suspected pathogenic mutation, prior chest radiation therapy at least 8 years earlier and before age 30, or estimated lifetime risk of at least 20% based on family history/prior biopsy history (22), between age 30 and 75.
- Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12).
- Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis.
- Women with a personal history of breast cancer diagnosed by age 50 or with dense breasts (21), beginning the year after diagnosis (will be recruited under separate ongoing TOCEM protocol).
- Women with heterogeneously dense breasts and any family history of breast cancer (about 36% of the screening population has dense breasts and about 20% have a family history of breast cancer) who do not meet current high-risk criteria, beginning at age 40 or ten years prior to the age of the youngest relative but not before age 30.
- Participants are expected to have medical or other reasons that they are not able to have screening breast MRI.
Exclusion
- Under age 30 or over age 75.
- Pregnant or breast feeding.
- Breast implants.
- Breast surgery within the prior 12 months.
- Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging).
- Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen).
- Reduced kidney function with eGFR \< 45 mL/min.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT04764292
Start Date
February 15 2021
End Date
May 30 2025
Last Update
September 11 2025
Active Locations (3)
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1
UPMC Magee at the Lemieux Sports Complex
Cranberry Township, Pennsylvania, United States, 16066
2
UPMC Magee Monroeville Breast Care Center
Pittsburgh, Pennsylvania, United States, 15146
3
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213