Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2015 |
| End Date: | October 2015 |
A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study
Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are
properly trained in the reading and interpretation of FFDM and DBT images.
Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are
properly trained in the reading and interpretation of FFDM and DBT images.
For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They
review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The
radiologists performance metrics for the following modalities will be evaluated: FFDM and
FFDM + DBT.
review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The
radiologists performance metrics for the following modalities will be evaluated: FFDM and
FFDM + DBT.
Inclusion Criteria:
- Female subjects participating in FMSU004A protocol with known clinical status
Exclusion Criteria:
- Subjects with unknown clinical status not participating in FMSU004A protocol.
We found this trial at
5
sites
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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