RECRUITING

Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-17
Study Completion:2024-09-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04877912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 74 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women that have had a mammographically and/or sonographically identified finding that will require image guided biopsy
  2. * Women between ages 40-74 with dense breasts having a mammogram
  3. * Women identified as having an average or intermediate risk of breast cancer (defined as 10- 20% lifetime risk based on a clinical risk model).
  1. * Women with metallic implants
  2. * Women that are claustrophobic
  3. * Women that have a fear of needles or contrast
  4. * Women that have had an allergic reaction to contrast in the past
  5. * Women that are pregnant
  6. * Women who are demonstrated to be at risk for an allergic reaction or nephrogenic systemic fibrosis (NSF)

Contacts and Locations

Study Contact

Rabia Safi, MD
CONTACT
773-702-2777
rsafi@radiology.bsd.uchicago.edu
Elle Hill, MA
CONTACT
ehill@radiology.bsd.uchicago.edu

Study Locations (Sites)

University of Chicago Mitchell Hospital
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-17
Study Completion Date2024-09-14

Study Record Updates

Study Start Date2020-09-17
Study Completion Date2024-09-14

Terms related to this study

Keywords Provided by Researchers

  • MRI Screening
  • Breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer