Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT03729115

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Interventions

Magnetic Resonance Imaging (MRI)

Study Details

Brief summary:

This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.

Conditions

Breast Cancer

Study ID

NCT03729115

Start date

May 30, 2019

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

OR

  • 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.

OR

  • 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.

  • Patients with prior history of breast or ovarian or any cancer associated with inherited pathogenic mutations in BRCA1/2, PALB2, CDH1, TP53, PTEN or STK11 related mutation are eligible if they meet the inclusion criteria, have completed all active treatments and are cancer free.
  • Willing to travel to the University of Chicago Medicine

Exclusion Criteria

  • 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.

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Screening Arm

Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.

Interventions

Magnetic Resonance Imaging (MRI)

Patients will have MRI scans every 6 months.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Cancer Clinical Intake Office

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Lorena Pineda

858-534-2010lopineda@health.ucsd.edu

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Genella Cipar

916-734-9004research-radiology-som@health.ucdavis.edu

University Of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Cancer Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Olufunmilayo Olopade, MD

More Information

Sponsor

University of Chicago

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-09-01.