Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: MRI Abbreviated Scan; Diagnostic test: Abbreviated MRI Scan

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Rabia Safi, MD; Phone Number: 773-702-2777; Email: rsafi@radiology.bsd.uchicago.edu
• Study Contact Backup: Name: Elle Hill, MA; Email: ehill@radiology.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Mitchell Hospital
      • Contact: Rabia Safi, MD; Phone Number: 773-702-2777; Email: rsafi@radiology.bsd.uchicago.edu
      • Contact: Elle Hill, MA; Email: ehill@radiology.bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: MRI Abbreviated Scan; All subjects will be receiving an MRI scan, up to 15 minutes long that includes an injection of contrast agent. This contrast agent will be injected into the arm and will help the doctors to read the MRI more effectively. If there is a lesion (abnormality) in the breast, the contrast agent will go to the lesion first and we will be able to see it better. The examination table will then move subject into the magnet, which is a long tube with a diameter of about 3 feet. Subject will be asked to lie in the magnet for about 15 minutes. During the periods when we are taking pictures, we will ask subject to be as still as possible.
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.	Diagnostic test: Abbreviated MRI Scan; All subjects will be receiving an MRI scan, up to 15 minutes long that includes an injection of contrast agent. This contrast agent will be injected into the arm and will help the doctors to read the MRI more effectively. If there is a lesion (abnormality) in the breast, the contrast agent will go to the lesion first and we will be able to see it better. The examination table will then move subject into the magnet, which is a long tube with a diameter of about 3 feet. Subject will be asked to lie in the magnet for about 15 minutes. During the periods when we are taking pictures, we will ask subject to be as still as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True Positive	The abbreviated scan successfully determines a cancer, confirmed by biopsy.	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Estimated): September 14, 2024
• Study Completion (Estimated): September 14, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Breast cancer; MRI Screening
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB16-0396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes