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New mammogram technique could spare thousands from unneeded breast biopsies

NCT ID NCT05206331

Diagnosis Sponsor: Margarita Louise Zuley Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study tests whether contrast-enhanced mammography (CEM) can safely reduce the number of breast biopsies for women with breast findings that are suspicious but not highly suspicious (BI-RADS 4A or 4B). About 2,100 women scheduled for a biopsy will first get a CEM. The goal is to see if CEM can correctly identify benign lesions and avoid at least 20% of unnecessary biopsies while still catching nearly all cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

2,089 people

The number who actually took part.

Started

Feb 2022

Finished

Aug 2026

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 years and older

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: * Subject is female of any race and ethnicity * Subject is ≥30 years old * Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy. Exclusion Criteria: * Subject is unable or unwilling to undergo informed consent * Subject has a breast implant in the breast of interest * Subject is pregnant * Subject is breast-feeding * Subject is actively being treated for cancer of any type with chemotherapy * Subject has reduced kidney function with eGFR \< 30. * Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.