Breast Cancer Clinical Trial

Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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)

Study is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT04877912

Recruitment Status:

Recruiting

Sponsor:

University of Chicago

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There is 1 Location for this study

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University of Chicago Mitchell Hospital
Chicago Illinois, 60637, United States More Info
Rabia Safi, MD
Contact
773-702-2777
[email protected]
Elle Hill, MA
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT04877912

Recruitment Status:

Recruiting

Sponsor:


University of Chicago

How clear is this clinincal trial information?

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