Development and Testing of an Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening - A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk. MRI, combined with other methods of risk assessment, has potential to significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases at a much earlier stage, with far fewer interval cancers than mammography. Previous tests of MRI sensitivity show that this screening could significantly increase the likelihood of detecting invasive cancers resulting in decreased mortality from breast cancer. Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists. Based on the radiologist determination that the MRI findings are suspicious (these findings include masses, non-mass enhancement and foci), suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0, 4 and 5. False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 74
Healthy Volunteers: t
View:

• Women that have had a mammographically and/or sonographically identified finding that will require image guided biopsy

• Women between ages 40-74 with dense breasts having a mammogram

• Women identified as having an average or intermediate risk of breast cancer (defined as 10- 20% lifetime risk based on a clinical risk model).

Locations
United States
Illinois
University of Chicago Mitchell Hospital
RECRUITING
Chicago
Contact Information
Primary
Rabia Safi, MD
rsafi@radiology.bsd.uchicago.edu
773-702-2777
Backup
Elle Hill, MA
ehill@radiology.bsd.uchicago.edu
Time Frame
Start Date: 2020-09-17
Estimated Completion Date: 2024-09-14
Participants
Target number of participants: 200
Treatments
Biopsy Group
We will scan 50 women who are scheduled for a breast biopsy. Subjects will receive an MRI exam that is research-only prior to the biopsy.
MRI Unknown Cancer Status Group
We will scan 150 women with dense breasts and/or women who have intermediate risk of breast cancer for this study. Subjects will receive an MRI exam that is research-only.
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov