Clinical trial · Observational
A Multi-Reader Multi-Case Pivotal Trial
A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus DBT Versus FFDM Alone in the Detection of Breast Cancer
NCT02692209CI-TRIAL-00045816completedResults 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 pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.
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 Alone | Device | — | UNRESOLVED |
| FFDM Plus DBT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- FFDM Plus DBT
- description
- FFDM Plus DBT images are being evaluated as compared to FFDM alone
- interventionNames
- Device: FFDM Plus DBT
- label
- Full Field Digital Mammography
- description
- Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT
- interventionNames
- Device: FFDM Alone
Primary outcomes (1)
- measure
- Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization.
- timeFrame
- 1 month
- description
- The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites. * Meet none of the exclusion criteria under protocol FMSU2013-004A. Exclusion Criteria: * Subjects who are in violation of protocol FMSU2013-004A. * Subjects who meet exclusion criteria under protocol FMSU2013-004A. * Subjects with unknown clinical status. * Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.
References
Publications (0)
Data not yet available
No reference posted for this study.