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

ConditionBreast Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age25+

SponsorUniversity of Chicago

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Magnetic Resonance Imaging (MRI)
Procedure/Surgery
Patients will have MRI scans every 6 months.

Treatment groups

400 Participants

are divided into 1 treatment group

Group A: Screening ArmOther 1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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