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Clinical Trials/NCT03929822
NCT03929822
Terminated
Not Applicable

Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy

Memorial Sloan Kettering Cancer Center1 site in 1 country32 target enrollmentApril 23, 2019

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2019
End Date
January 19, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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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