N/A
N=600
Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03586583 ↗Enrolled (actual)
600
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Comparison of ISR (Modified Processing) to FBP (Original Processing) — 0.83; 0.83; 0.80; 0.79 5-point scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- FBP (Device); ISR (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fujifilm Medical Systems USA, Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of ISR (Modified Processing) to FBP (Original Processing) |
0.83; 0.83; 0.80; 0.79; 0.84; 0.83 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03586583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.