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New mammogram technique could reduce unnecessary breast biopsies

NCT ID NCT05046301

Diagnosis Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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)
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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.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study looks at whether a special type of mammogram called contrast-enhanced mammography (CEM) can more accurately predict breast cancer in women with suspicious calcium spots in the breast. About 59 women with large areas of these spots will get both a standard mammogram and a CEM. The goal is to see if CEM reduces false alarms and helps avoid unnecessary biopsies.

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.

Participants

59 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

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.

Who is studied

Patients with suspicious mammographic microcalcifications

Ages

25 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Women with suspicious mammographic microcalcifications (Breast Imaging Reporting and Data System \[BI-RADS\] categories 4 or 5) occupying an area equal to or exceeding 4 cm in diameter and recommended for a stereotactic biopsy, who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their stereotactic biopsy at MDACC. * Age 25-85 years * Willing to participate in the study, undergo an intravenous (IV) placement, able to undergo iodinated contrast injection, and able to provide informed consent Exclusion Criteria: * Reported history of an allergic reaction to iodinated contrast * History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast * Renal insufficiency * Pregnancy or lactation within 6 months * Breast surgery affecting the site of interest within prior 6 months * Breast biopsy at the site of interest within the last 2 months * Mammographic mass or architectural distortion associated with the calcifications in question

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast carcinoma

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

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