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No-Needle breast MRI: AI could replace contrast dye for cancer detection

NCT ID NCT07598084

Diagnosis Sponsor: Peking University People's Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test if artificial intelligence can create clear breast MRI images without using contrast dye. Researchers will use a special type of MRI scan (diffusion-weighted imaging) to generate synthetic images that might help diagnose breast cancer. If successful, this could allow some women at lower risk to avoid the contrast injection. The study plans to enroll 12,000 adults who need a breast MRI for screening or diagnosis.

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

About 12,000 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 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

Participants who underwent breast MR examinations at five institutions from 2014 to 2024 were enrolled. A test cohort prospectively collected at Peking University People's Hospital Health Examination Center, was enrolled to assess the robustness of the model.

Ages

18 years and older

Sex

Anyone

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: 1. Complete breast MRI data; 2. Negative pathology biopsy results or negative follow-up examinations for at least 12 months for non-cancer cases; 3. Positive biopsy results that meet the requirements for the pathological subtype of cancer for cancer cases; 4. Original data that can be used to verify clinical status, including radiological and pathological reports; Exclusion Criteria: 1. Partial mastectomy or puncture biopsy on the diseased side of the breast prior to breast MRI examination; 2. Poor image quality; 3. Implants in the affected breast;

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Conditions

The condition(s) this trial relates to.

breast neoplasm

As listed by the trial registrant

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

Artificial intelligence (AI) Breast neoplasms Deep learning Diffusion magnetic resonance imaging Magnetic resonance imaging (MRI)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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