NCT03729115

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
32mo left

Started May 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2019Dec 2028

First Submitted

Initial submission to the registry

October 12, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 27, 2026

Status Verified

September 1, 2025

Enrollment Period

9.6 years

First QC Date

October 12, 2018

Last Update Submit

April 22, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Study Arms (1)

Screening Arm

OTHER

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

Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI)PROCEDURE

Patients will have MRI scans every 6 months.

Screening Arm

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.
  • With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR
  • years risk ≥ 6% for women 40-64 OR
  • years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk \>= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR
  • Patients with history of chest wall radiation received before age 35. OR
  • To promote health equity, women of African Ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women.
  • 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 cancer are eligible if they have completed all active treatments and are cancer free for two years.

You may not qualify if:

  • Undergoing active cancer treatment at the time of enrollment.
  • Current pregnancy or plans for pregnancy within two years of enrollment.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Olufunmilayo I Olopade, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Clinical Intake Office

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

November 2, 2018

Study Start

May 30, 2019

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 27, 2026

Record last verified: 2025-09

Locations

US(1)