Clinical trial · Observational
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study
NCT01928992CI-TRIAL-000248493DMcompletedClinicalTrials.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 study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.
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 |
|---|---|---|---|
| 2D | Device | — | UNRESOLVED |
| 3D | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 3D
- description
- Subjects that undergo 3D mammography
- interventionNames
- Device: 3D
- label
- 2D
- description
- Subjects that undergo 2D mammography
- interventionNames
- Device: 2D
Primary outcomes (1)
- measure
- Per Breast AUC
- timeFrame
- 1 Day
- description
- Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects participating in prior FMSU protocol with known clinical status Exclusion Criteria: * Subjects with unkown clinical status * Subjects not truthed in prior FMSU study
References
Publications (0)
Data not yet available
No reference posted for this study.