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

Official record

Identifier

NCT03729115

Recruiting locations

country

United States

Interventions studied

Magnetic Resonance Imaging (MRI)

Lead sponsor

University of Chicago

Target enrolment

400 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Nov 2, 2018

Last updated on the registry

Sep 1, 2026

Age

25 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Breast Cancer