Improving Characterization of Calcifications With Contrast-Enhanced Mammography
NCT03639129 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-05-14
Summary
The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.
Conditions
- Mammography
Interventions
- DEVICE
-
Contrast-enhanced mammography
Contrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world
- PROCEDURE
-
Biopsy
Standard of care
Sponsors & Collaborators
-
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Matthew Covington, M.D. · Washington University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-31
- Primary Completion
- 2021-05-31
- Completion
- 2021-05-31
- FDA Device
- Yes
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