New mammogram technique could replace MRI for High-Risk women

NCT ID NCT04764292

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Recruiting now
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Not yet recruiting
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By invitation only
Not open to general applications. Only people the study team invites can take part.
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Ongoing
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Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

615 people

The number who actually took part.

Started

Feb 2021

Finished

May 2025

Lead sponsor

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

30 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

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

  • Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Magee Monroeville Breast Care Center

    Pittsburgh, Pennsylvania, 15146, United States

  • UPMC Magee at the Lemieux Sports Complex

    Cranberry Township, Pennsylvania, 16066, United States

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