Screening Contrast-Enhanced Mammography as an Alternative to MRI (NCT04764292) | Clinical Trial Compass
CompletedPhase 4
Screening Contrast-Enhanced Mammography as an Alternative to MRI
United States601 participantsStarted 2021-02-15
Plain-language 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, 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.
Who can participate
Age range30 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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.