Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 3, 2017 |
| End Date: | February 15, 2018 |
A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pilot Study
The purpose of this pilot is to provide credible performance estimate information in order to
conduct a subsequent pivotal reader study.
conduct a subsequent pivotal reader study.
This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with
an enriched sample of 100 breast screening or diagnostic cases which were selected from the
library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects
previously provided written informed consent agreeing their image data and supporting
documentation could be used for future research and investigations). Approximately 6
qualified radiologists will independently perform two reads on all (approximately 100) cases.
Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE
Bellus II workstation.
an enriched sample of 100 breast screening or diagnostic cases which were selected from the
library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects
previously provided written informed consent agreeing their image data and supporting
documentation could be used for future research and investigations). Approximately 6
qualified radiologists will independently perform two reads on all (approximately 100) cases.
Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE
Bellus II workstation.
Inclusion Criteria:
- Female subjects participating in FMSU2013-004A protocol with known clinical status
Exclusion Criteria:
- Female subjects that did not have known clinical status in FMSU2013-004A
We found this trial at
1
site
Click here to add this to my saved trials
