Breast Cancer
Conditions
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.
Interventions
PROCEDUREMagnetic Resonance Imaging (MRI)
Patients will have MRI scans every 6 months.
Sponsors
University of Chicago
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTCancer Clinical Intake Office
PRINCIPAL_INVESTIGATOROlufunmilayo I Olopade, MD
University of Chicago
Outcome results
None listed