N/A
N=100
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02511730 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM — 100; 100 Probability
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FFDM Plus DBT (Device); FFDM (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fujifilm Medical Systems USA, Inc.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM |
100; 100 | — |
Summary
The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.
Eligibility Criteria
Inclusion Criteria
- Female subjects participating in FMSU004A protocol with known clinical status
Exclusion Criteria
- Subjects with unknown clinical status not participating in FMSU004A protocol.
Data sourced from ClinicalTrials.gov (NCT02511730). 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.