NCT05206331View on ClinicalTrials.gov

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

PHASE4RecruitingINTERVENTIONAL

Enrollment

2,100

Participants

Timeline

Start Date

February 1, 2022

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2027

Conditions

Breast Cancer

Interventions

DEVICE

contrast enhanced mammography

Dual-energy contrast images; low-energy CEM images will be obtained with a kilovoltage below 35 kVp while the high-energy images will be obtained with 45-49 kVp.The average glandular dose of the CEM procedure is approximately 2.44 mGy per view

DRUG

Iodinated Contrast Media (ICM)

standard FDA-approved low osmolarity Iodine contrast agent with 350-370 mg/ml

Trial Locations (1)

15213

RECRUITING

UPMC Magee-Womens Hospital, Pittsburgh

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

Margarita Louise Zuley

OTHER

NCT05206331 - CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study | Biotech Hunter | Biotech Hunter