Recruiting

CEM

Sponsor:

Margarita Louise Zuley

Code:

NCT05206331

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Accepted

Interventions

contrast enhanced mammography

Iodinated Contrast Media (ICM)

Study Details

Brief 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%.

Conditions

Breast Cancer

Study ID

NCT05206331

Start date

Feb 1, 2022

Status verified date

Oct, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subject is unable or unwilling to undergo informed consent
  • Subject has a breast implant in the breast of interest
  • Subject is pregnant
  • Subject is breast-feeding
  • Subject is actively being treated for cancer of any type with chemotherapy
  • Subject has reduced kidney function with eGFR < 30.
  • Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast

Study Design

Enrollment

2100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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

Iodinated Contrast Media (ICM)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

UPMC Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

Margarita Louise Zuley

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Margarita Louise Zuley on 2025-10-08.