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New breast scan could rival MRI for detecting tumors

NCT ID NCT05754749

Diagnosis Sponsor: UNC Lineberger Comprehensive Cancer Center 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This pilot study compares contrast-enhanced digital breast tomosynthesis (CE-DBT) to standard MRI in 20 women with known breast lesions. Researchers want to see if CE-DBT can give doctors similar confidence in identifying suspicious areas. If it works, it might offer a quicker or more comfortable option for some patients.

What this could mean

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

Active substance
Iohexol (contrast agent)
What this could lead to
If successful, CE-DBT could become a more accessible or faster alternative to MRI for evaluating breast lesions, potentially improving diagnosis.
What could go wrong
This is a very early pilot study with only 20 participants, so results may not apply broadly. The new method may not match MRI's accuracy.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

4 people

The number who actually took part.

Started

Mar 2023

Finished

May 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

18 years and older

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 at least 18 years old * Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan * Suspected breast lesion based on prior imaging (BIRADS 4 or greater) * Able to provide written informed consent Exclusion Criteria: * Severe untreatable claustrophobia * Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants) * Known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids) * Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis * Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)

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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

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

More trials for these conditions

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