N/A
N=100
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03491917 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC) — 0.819; 0.796 Probability — p=<0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- DBT plus S-View (Device); FFDM alone (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fujifilm Medical Systems USA, Inc.
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC) |
0.819; 0.796 | <0.01 sig |
Summary
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
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 (NCT03491917). 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.