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Breast Cancer Surveillance Program for High-Risk Women

This study is creating a registry of women at high risk for breast cancer to find better ways to detect it early. It's testing if Magnetic Resonance Imaging (MRI) scans every six months can help develop faster, personalized screening plans. You might be able to join if you are a woman aged 25 or older with certain genetic mutations (like BRCA1 or BRCA2) or a high lifetime risk of breast cancer. The study aims to see if these faster MRI protocols can be developed within five years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 400 women.
What's involved
Participants will have MRI scans every 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03729115

A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer

Recruiting
NAAges 25+InterventionalScreening
University of Chicago
~400 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Magnetic Resonance Imaging (MRI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.
Measured over 5 years

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaBRCA1 GeneBRCA2 GeneCDH1 GenePartner and Localizer of BRCA2PTEN GeneSTK11 GeneTP53 Gene

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Olufunmilayo I Olopade, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Cancer Clinical Intake Office
[email protected]
1-855-702-8222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Known carrier of PV in BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 or STK11 gene. Women with PV in any other cancer susceptibility genes are eligible if they also have an estimated lifetime risk of 30% or higher based on the integrated risk score, as described below.
Results from a CLIA approved laboratory with estimated lifetime risk of 30% or higher, based on integrated risk score that includes polygenic risk score (PRS) e.g Myriad Model.
WISDOM study participant recommended to have MRI every 6 months. OR
Patients with history of chest wall radiation received before age 35. AND
Must be at least 25 years old.
Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
Be able to give informed consent.
Willing to travel to the University of Chicago Medicine

Exclusion

Undergoing active cancer treatment at the time of enrollment.
Current pregnancy.
Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
Breast surgery within two weeks of study entry.
Women with history of bilateral mastectomy are not eligible
History of kidney disease or abnormal kidney function.
History of dye allergy unless it can be mediated with antihistamines and/or steroids
Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.
Women who are pregnant can return to the study after pregnancy. Expected timeframe to return back to the study after pregnancy is within 6 months post-delivery.
Women can return to the study after being treated for early-stage breast cancer. Timing of return to the study will be per investigator's discretion.

What this trial measures

  • Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.5 years

    We will test whether an abbreviated MRI (AB-MRI) is diagnostically equivalent to a full MRI. Eligible women will be scanned every 6 months with a full protocol MRI.