New mammogram technique could replace MRI for High-Risk women
NCT ID NCT04764292
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study looked at whether a special type of mammogram called contrast-enhanced mammography (CEM) can be used instead of MRI to screen for breast cancer in women at high risk. The study included 615 women who could not have an MRI due to reasons like claustrophobia or implants. Researchers compared how well CEM found cancers compared to standard mammography alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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615 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria: 1. 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. 2. Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12). 2. Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis. 3. 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). 4. 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 Criteria: 1. Under age 30 or over age 75. 2. Pregnant or breast feeding. 3. Breast implants. 4. Breast surgery within the prior 12 months. 5. Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging). 6. Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen). 7. Reduced kidney function with eGFR \< 45 mL/min.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
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UPMC Magee Monroeville Breast Care Center
Pittsburgh, Pennsylvania, 15146, United States
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UPMC Magee at the Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066, United States
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