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Can a new MRI scan reduce unnecessary breast biopsies?

NCT ID NCT04491864

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a special type of MRI called DWIBS can better identify suspicious breast lesions found on mammograms and ultrasounds. The goal was to see if it could accurately tell benign from malignant lesions and potentially reduce false-positive biopsies. Only 11 women were enrolled before the study was terminated, so the findings are limited.

What this could mean

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

What this could lead to
If successful, this could lead to a more accurate imaging method to reduce unnecessary breast biopsies.
What could go wrong
The trial was terminated early with only 11 participants, so results are very limited and may not be reliable.

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

11 people

The number who actually took part.

Started

Mar 2019

Finished

Jul 2022

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

Genetically female patients age 30 and greater with suspicious BIRADS 4 or BIRADS 5 masses and/or asymmetries on standard 2D/3D mammogram and ultrasound imaging

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: * A patient will be eligible for inclusion in this study if she meets all of the following criteria: 1. \>30 years of age 2. Genetic Female 3. Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging. Exclusion Criteria: * A patient is ineligible for inclusion in this study if she meets any of the following criteria: 1. Prior biopsy of suspicious lesion 2. Breast implants 3. Prior history of breast cancer 4. Patient has a pacemaker 5. Contraindications to use of MRI imaging (metal implants, etc.) 6. Woman pregnant or lactating 7. Calcifications as only findings present for a suspicious lesion

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Baylor Scott & White Research Insitute

    Dallas, Texas, 75246, United States

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