Clinical trial · Interventional
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
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
NCT02685566CI-TRIAL-00069746completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FFDM | Device | — | UNRESOLVED |
| FFDM Plus DBT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FFDM Plus DBT
- description
- Breast Images with FFDM and DBT
- interventionNames
- Device: FFDM Plus DBT
- type
- ACTIVE_COMPARATOR
- label
- Full-Field Digital Mammography
- description
- Breast Images with FFDM alone
- interventionNames
- Device: FFDM
Primary outcomes (1)
- measure
- Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects participating in FMSU004A protocol with known clinical status Exclusion Criteria: * Subjects with unknown clinical status not participating in FMSU004A protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.