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NCT02685566 · ClinicalTrials.gov registry record · NA
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
A NA study of Breast Cancer, sponsored by Fujifilm Medical Systems USA.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 5
- Study locations
NCT02685566: Completed NA study of Breast Cancer, sponsored by Fujifilm Medical Systems USA.
NCT02685566 is a NA study of Breast Cancer that has completed, run by Fujifilm Medical Systems USA. The registered enrollment target is 100 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02685566, a NA study of Breast Cancer, has completed, sponsored by Fujifilm Medical Systems USA.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant
Conditions Studied
Interventions
- DEVICE FFDM Plus DBT
- DEVICE FFDM
Study Locations (5)
Arizona
- Scottsdale Medical Imaging, Limited (SMIL) - Scottsdale
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
New York
- Elizabeth Wende Breast Care, LLC (EWBC) - Rochester
North Carolina
- University of North Carolina - at Chapel Hill - Chapel Hill
Texas
- University of Texas Health Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-08 |
| Est. Completion | 2015-10 |
| Phase | NA |
What the finished NCT02685566 record still lists
NCT02685566 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which FFDM Plus DBT is the first listed.
NCT02685566 lists 5 locations in 5 states (Arizona, Iowa, New York).
Frequently Asked Questions
What is clinical trial NCT02685566 about?
NCT02685566 is a clinical study titled "Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program". 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.
What is the current status of trial NCT02685566?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2015-08. Estimated completion is 2015-10.
What conditions does trial NCT02685566 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02685566?
The interventions under investigation include: FFDM Plus DBT (DEVICE), FFDM (DEVICE).
Who is sponsoring clinical trial NCT02685566?
This trial is sponsored by Fujifilm Medical Systems USA, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02685566 being conducted?
This trial has 5 study locations across Arizona, Iowa, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02685566's enrollment target sits among peer trials
100 565th of 1224 higher than 630 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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