A Multi-Modality Surveillance Program in Screening Women at High Risk for Breast Cancer
- Known BRCA1 or BRCA2, TP53, PALB2 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high Polygenic Risk Score (PRS). OR
- With life time risk of 40% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors.
- Without prior breast cancer.
- Willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.
- Be able to give informed consent.
- Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors or participating in a chemoprevention trial.
- Active cancer 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 objects in their body that interferes with an MRI.
- Breast surgery within two weeks of study entry.
- History of kidney disease or abnormal kidney function.
I. Develop faster MRI protocols for a personalized risk-based imaging surveillance model (PRISM) for diverse populations of high risk women.
II. Evaluate multi-modal intervention for anxiety-reduction in the setting of intensive surveillance for women with inherited highly penetrant mutations in breast cancer susceptibility genes including BRCA mutations and other genes.
I. Establish a patient database of serial patient images to develop imaging markers integrated with biomarkers for breast cancer risk on which to draw for future studies.
II. Evaluate the cost effectiveness of an intensified screening regimen consisting of semi-annual MRI in women with mutations in breast cancer susceptibility genes.
Participants receive a workbook comprising cognitive-behavioral self-management of anxiety therapy and listen to an audio recording of clinical hypnosis before each MRI screen. Participants undergo DCE MRI every 6 months and undergo screening mammogram annually for 5 years. During the MRI screening procedure, participants will rate verbally self-reported anxiety.
After completion of study, participants are followed up annually. During the baseline visit and at each follow-up screening, participants will complete self-report psychosocial assessments and a series of adapted questions on perception of breast and ovarian cancer risk.
Trial Phase Phase NA
Trial Type Screening
University of Chicago Comprehensive Cancer Center
Olufunmilayo Falusi Olopade
- Primary ID IRB18-0970
- Secondary IDs NCI-2019-01587
- Clinicaltrials.gov ID NCT03729115