Clinical trial · Interventional
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm Full Field Digital Mammography (FFDM) Plus Digital Breast Tomosynthesis (DBT) Versus FFDM Alone in the Detection of Breast Cancer
NCT02511730CI-TRIAL-00069726completedN/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 provide credible performance estimate information in order to conduct subsequent reader studies.
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
- FFDM Alone
- description
- Breast Images with FFDM alone
- interventionNames
- Device: FFDM
Primary outcomes (1)
- measure
- Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM
- timeFrame
- 1 month
- 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.