N/A
Completed N=150
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
Source: ClinicalTrials.gov NCT03501693 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Compare Per Subject AUC: DBT Plus S-View Versus FFDM — 0.794; 0.764 Probability
Summary
The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Per Subject AUC: DBT Plus S-View Versus FFDM |
0.794; 0.764 | — |
| SECONDARY Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM |
0.342; 0.415 | — |
| SECONDARY Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases |
0.679; 0.643 | — |
| SECONDARY Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM |
0.679; 0.643 | — |
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 (NCT03501693). 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. Informational only — not medical advice.