Clinical trial · Observational
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
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
NCT03491917CI-TRIAL-00045594completedResults 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 a subsequent pivotal reader 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 |
|---|---|---|---|
| DBT plus S-View | Device | — | UNRESOLVED |
| FFDM alone | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- DBT plus S-View
- description
- Breast images utilizing DBT plus S-View
- interventionNames
- Device: DBT plus S-View
- label
- FFDM alone
- description
- Breast images using FFDM alone only
- interventionNames
- Device: FFDM alone
Primary outcomes (1)
- measure
- Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)
- timeFrame
- 2 visits with 4 week washout period
- description
- Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.