N/A
Completed N=100
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
Source: ClinicalTrials.gov NCT02685566 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate — .805; 0.756 probability
Summary
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate |
.805; 0.756 | — |
| SECONDARY Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization. |
0.805; 0.777 | — |
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 (NCT02685566). 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.