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New mammogram tech could spot hidden breast cancers in dense tissue

NCT ID NCT05667532

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study is testing whether contrast-enhanced mammography (CEM) can find breast cancers better than standard mammography in women with dense breasts. Dense breast tissue can hide tumors on regular mammograms, so better imaging is needed. Researchers will enroll 1,000 women aged 30–75 with dense breasts to compare the two methods. The goal is to see if CEM improves cancer detection and risk assessment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Contrast-Enhanced Mammography (CEM)
What this could lead to
If successful, CEM could become a more accurate screening tool for women with dense breasts, catching cancers earlier and reducing false alarms.
What could go wrong
This is an observational screening study, not a treatment trial. CEM may not prove significantly better than standard mammography, and results may not apply to all women.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2028

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.

Ages

30 to 75 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: 1. Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites 2. Willingness to co-enroll or currently enrolled in PA17-0584 3. Willingness to participate in the study and ability to provide informed consent Exclusion Criteria: 1. Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain. 2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding 3. Personal history of breast cancer (DCIS or invasive breast cancer) 4. Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer 5. Breast biopsy within 6 months 6. Breast surgery within 12 months 7. Breast MRI, MBI, or CEM performed within 24 months 8. Known allergy to iodine-containing contrast agents 9. 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 10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)

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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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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