Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

Recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: MRI Abbreviated Scan; Diagnostic Test: Abbreviated MRI Scan

• Registration Number: NCT04877912
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-17
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2024-09-14
• Study Completion: 2024-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biopsy Group	MRI Abbreviated Scan	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	Abbreviated MRI Scan	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.

Primary Outcome Measures

Name	Time	Method
True Positive	1 day	The abbreviated scan successfully determines a cancer, confirmed by biopsy.

Secondary Outcome Measures

Name	Time	Method
True Negative	1 day	The abbreviated scan successfully determines no cancers are present, as confirmed with mammography or a standard MRI.

Trial Locations

Locations (1)

University of Chicago Mitchell Hospital; 🇺🇸 Chicago, Illinois, United States