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Can MRI and tissue tests predict breast cancer before it starts?

NCT ID NCT03303846

Knowledge-focused Sponsor: City of Hope Medical 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether combining breast MRI with blood and tissue samples can help find early signs of breast cancer in high-risk women. About 344 women will undergo standard screening MRI and donate leftover tissue and blood. The goal is to better understand how normal breast tissue changes might signal cancer risk.

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 better ways to predict breast cancer risk in high-risk women using imaging and biomarkers.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change patient care or outcomes.

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

344 people

The number who actually took part.

Started

Oct 2017

Expected to finish

Nov 2026

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

18 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: * Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening * Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery * Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn * Documented informed consent of the participant Exclusion Criteria: * Allergy or intolerance to gadolinium * Inability to undergo breast MRI (e.g. claustrophobia) * Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ) * Previous diagnosis of stage 4 cancer * Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI * Participants who have received endocrine therapy within 1 year prior to screening breast MRI * Participants who have received breast radiation within 1 year prior to screening breast MRI * Radiation to both breasts * Pregnant and/or lactating within 1 year prior to screening breast MRI * Receives screening breast MRIs at an outside facility other than the consenting institution

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Healthy subject

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Ohio State University, Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Wisconsin

    Madison, Wisconsin, 537192, United States

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