Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

Stopped early

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04877912

Run by

University of Chicago

People needed

166

Starts

2017-06-01

Expected to finish

2022-05-31

Last updated by the study team

2026-03-20

Who can join

Age: 40 and older, up to 74. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• Women with metallic implants
• Women that are claustrophobic
• Women that have a fear of needles or contrast
• Women that have had an allergic reaction to contrast in the past
• Women that are pregnant
• Women who are demonstrated to be at risk for an allergic reaction or nephrogenic systemic fibrosis (NSF)

Where it is running

• University of Chicago Mitchell Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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