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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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%.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Healthy Volunteers: t
View:

• Subject is female of any race and ethnicity

• Subject is ≥30 years old

• Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy.

Locations
United States
Pennsylvania
UPMC Magee-Womens Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Suzanne Burdin, BS
burdins@upmc.edu
412-647-7385
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 2100
Treatments
Experimental: contrast enhanced mammography
Women who have been recently diagnosed with a suspicious abnormality for which they have scheduled a breast biopsy and meet inclusion criteria will be invited to have a contrast enhanced mammography before their scheduled biopsy procedure.
Related Therapeutic Areas
Sponsors
Leads: Margarita Louise Zuley
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov