N/A
Completed N=298
A Multi-Reader Multi-Case Pivotal Trial
Source: ClinicalTrials.gov NCT02692209 ↗Enrolled (actual)
298
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization. — 0.837; 0.784 Probability
Summary
The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization. |
0.837; 0.784 | — |
Eligibility Criteria
Inclusion Criteria
- Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.
- Meet none of the exclusion criteria under protocol FMSU2013-004A.
Exclusion Criteria
- Subjects who are in violation of protocol FMSU2013-004A.
- Subjects who meet exclusion criteria under protocol FMSU2013-004A.
- Subjects with unknown clinical status.
- Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.
Data sourced from ClinicalTrials.gov (NCT02692209). 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.