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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Margarita Louise Zuley
Study ID
NCT05206331
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
30 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • contrast enhanced mammography — DEVICE
    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
  • Iodinated Contrast Media (ICM) — DRUG
    standard FDA-approved low osmolarity Iodine contrast agent with 350-370 mg/ml

Study Details

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%.

Key Dates

Start date
Feb 1, 2022
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
2,100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Negative Predictive Value (NPV) [ Time Frame: year 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Magee-Womens HospitalPittsburghPennsylvania15213
Suzanne Burdin, BS
[email protected]
412-647-7385

Find similar trials in Pittsburgh, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UPMC Magee-Womens Hospital· Pittsburgh, PA

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