NCT03929822
Terminated
Not Applicable
Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy
ConditionsBreast Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Screening
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of CESM compared to mammography
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.
Exclusion Criteria
- •Age \<30 years old
- •Screening mammography with only calcifications abnormalities
- •Male patients
- •Pregnant or lactating patients
- •Patients with any allergy to iodinated contrast
- •Patients with eGFR \< 45
- •Patients that may be treated with radioactive iodine
Outcomes
Primary Outcomes
Diagnostic accuracy of CESM compared to mammography
Time Frame: 2 years
The radiologist will interpret the low energy images and record their findings.
Study Sites (1)
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