Clinical trial · Observational
Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
A Feature Comparison Study to Evaluate the Modified Processing of Fujifilm's ASPIRE Cristalle With Digital Breast Tomosynthesis Option as Compared to the Original Processing
NCT03586583CI-TRIAL-00069754completedResults 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 the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).
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 |
|---|---|---|---|
| FBP | Device | — | UNRESOLVED |
| ISR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- FBP (old processing)
- description
- Filtered back projection; old processing.
- interventionNames
- Device: FBP
- label
- ISR (new processing)
- description
- Iterative super resolution; new processing.
- interventionNames
- Device: ISR
Primary outcomes (1)
- measure
- Comparison of ISR (Modified Processing) to FBP (Original Processing)
- timeFrame
- 1 day reading session
- description
- For each reader, the cases judged as non-inferior with modified processing will be calculated for each feature and each view. Non-inferiority will be defined as a score of equivalence between modified and original or a score indicating the modified image processing is superior. Readers compared several general mammographic features using the following 5-point scale: negative 2 (left image much superior) negative 1 (left image somewhat superior) 0 (left and right images are equivalent) positive 1 (right image somewhat superior) positive 2 (right image much superior)
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.