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

The purpose of the Personalized Risk-based Imaging Surveillance Model (PRISM) study is to develop a personalized approach to screening women at high risk for breast cancer in diverse populations. A multi-modality surveillance program includes cognitive-behavioral self-management of anxiety therapy, clinical hypnosis, dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI), and mammogram. This study will also evaluate quality of life and measures of psychological well-being during breast cancer screening and compare breast MRI and mammogram in a high-risk population. Additionally, it will evaluate whether a new intervention for anxiety-reduction will help to improve adherence in high risk women undergoing intensive surveillance. Women participating in this study will learn self-management of anxiety using a technique called clinical hypnosis, which may help participants feel more relaxed during MRI. DCE MRI and mammogram may help doctors to detect breast cancer earlier when it is easier to treat.

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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

Lead Organization
University of Chicago Comprehensive Cancer Center

Principal Investigator
Olufunmilayo Falusi Olopade

• Primary ID IRB18-0970
• Secondary IDs NCI-2019-01587
• Clinicaltrials.gov ID NCT03729115