RECRUITING

CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

Conditions

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

One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM) has the potential to significantly reduce biopsy rates for commonly seen benign breast lesions while preserving very high cancer detection. The investigators propose a prospective clinical study of patients with diagnostic mammograms rated as BIRADS 4A or 4B and scheduled for a biopsy, in which, prior to undergoing their scheduled biopsy, a CEM procedure is performed. The investigators will test the primary hypothesis that for soft tissue lesions (i.e. masses, asymmetries, architectural distortions) initially rated BI-RADS 4A/4B adding CEM will reduce, by at least 20%, the number of biopsy recommendations for actually benign cases and, at the same time, provide a negative predictive value (NPV) higher than 95%.

Official Title

Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

Quick Facts

Study Start:2022-02-01
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05206331

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:30 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is female of any race and ethnicity
  2. * Subject is ≥30 years old
  3. * Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy.
  1. * Subject is unable or unwilling to undergo informed consent
  2. * Subject has a breast implant in the breast of interest
  3. * Subject is pregnant
  4. * Subject is breast-feeding
  5. * Subject is actively being treated for cancer of any type with chemotherapy
  6. * Subject has reduced kidney function with eGFR \< 45.
  7. * Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast

Contacts and Locations

Study Contact

Suzanne Burdin, BS
CONTACT
412-647-7385
burdins@upmc.edu

Principal Investigator

Margarita L Zuley, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Margarita Louise Zuley

  • Margarita L Zuley, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2022-02-01
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2027-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer