Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877912
• Other study ID #: IRB16-0396
• Status: Recruiting
• Start date: September 17, 2020
• Est. completion date: September 14, 2024

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Rabia Safi, MD
• Phone: 773-702-2777
• Email: rsafi[@]radiology.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 14, 2024
• Est. primary completion date: September 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Mitchell Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True Positive	The abbreviated scan successfully determines a cancer, confirmed by biopsy.	1 day
Secondary	True Negative	The abbreviated scan successfully determines no cancers are present, as confirmed with mammography or a standard MRI.	1 day