Screening Contrast-Enhanced Mammography as an Alternative to MRI
Completed · Phase 4
Conditions studied: Breast Cancer
In brief
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, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.
Key facts
- Study ID
- NCT04764292
- Run by
- Wendie Berg
- People needed
- 615
- Starts
- 2021-02-15
- Expected to finish
- 2025-05-30
- Last updated by the study team
- 2026-05-22
Who can join
Age: 30 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UPMC Magee at the Lemieux Sports Complex — Cranberry Township, Pennsylvania, United States
- UPMC Magee Monroeville Breast Care Center — Pittsburgh, Pennsylvania, United States
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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