Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

NCT04877912 | Terminated Results

• 2 other identifiers: IRB16-03965R01CA276652-02
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

MRI Screening; Breast cancer

Outcome Measures

Primary Outcomes (1)

• True Positive

  The number of abbreviated scans that successfully determines a cancer, confirmed by biopsy, based on the radiologist determination that the MRI findings are suspicious. Suspicious lesions were assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0 (incomplete - need additional imaging evaluation), 4 (suspicious for malignancy - biopsy should be considered) and 5 (highly suggestive of malignancy - appropriate action should be taken).

  30 days

Secondary Outcomes (1)

• True Negative

  30 days

Study Arms (2)

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

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

Interventions

Abbreviated MRI Scan DIAGNOSTIC_TEST

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

MRI Abbreviated Scan DIAGNOSTIC_TEST

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.

Biopsy Group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Chicago: lead

Study Sites (1)

University of Chicago Mitchell Hospital

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

This is not an interventional study.

Results Point of Contact

• Title: Gregory Karczmar
• Organization: University of Chicago

gskarczm@uchicago.edu

773-702-0214

Study Officials

• Gregory Karczmar, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 7, 2021
• Study Start: June 1, 2017
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-03

Locations

US (1)