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New contrast mammography could spot breast cancer recurrence earlier

NCT ID NCT06105749

Diagnosis Sponsor: Wendie Berg 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study is testing whether adding a special type of mammogram (contrast-enhanced mammography, or CEM) every two years to the standard yearly 3D mammogram can find new breast cancers in women who have already had breast cancer. The goal is to see if CEM detects more cancers while keeping false alarms low. About 1,500 women aged 30-79 who are at least one year past their breast cancer treatment will participate.

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, this could lead to a more accurate screening method for women who have had breast cancer, catching new cancers earlier with fewer false alarms.
What could go wrong
This is a single-arm study without a control group, so results may not prove superiority over standard screening. Also, CEM requires an IV contrast injection, which carries a small risk of allergic reaction.

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 1,600 people

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

Started

Nov 2023

Expected to finish

Apr 2031

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 79 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: * Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT). Exclusion Criteria: * Women with a history of prior moderate or severe iodinated contrast reaction \[only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded\]. * Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions. * Women who have had bilateral mastectomy * Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) \< 30 mL/min * Pregnancy or lactation * Women actively being treated for cancer of any type with chemotherapy. * Women with stage 4 metastasis to visceral areas or brain * Women with known personal history of breast cancer who have a screening breast MRI exam within 24 months prior to the current round of CEM. * Women with known personal history of breast cancer who had a CEM exam within the prior 23 months

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma neoplasm

As listed by the trial registrant

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

Breast cancer Breast cancer female Breast neoplasms Neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hillman Cancer Center at Shadyside

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Magee Womancare Monroeville

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • Magee-Womens Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Magee at the Lemieux Sports Complex

    RECRUITING

    Cranberry Township, Pennsylvania, 16066, United States

  • UPMC Magee-Womens Imaging - Bethel Park

    RECRUITING

    Bethel Park, Pennsylvania, 15102, United States

  • UPMC West Mifflin Outpatient Center

    RECRUITING

    West Mifflin, Pennsylvania, 15236, United States

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