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NCT03491917 · ClinicalTrials.gov registry record
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
A clinical trial, sponsored by Fujifilm Medical Systems USA.
- Completed
- Registry status
- 100
- Enrollment target
NCT03491917: Completed study, sponsored by Fujifilm Medical Systems USA.
NCT03491917 is a clinical trial that has completed, run by Fujifilm Medical Systems USA. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03491917 has completed, sponsored by Fujifilm Medical Systems USA.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
Primary Outcome
Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localizat
Interventions
- DEVICE DBT plus S-View
- DEVICE FFDM alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-11-03 |
| Est. Completion | 2018-02-15 |
What the finished NCT03491917 record still lists
NCT03491917 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which DBT plus S-View is the first listed.
NCT03491917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03491917 about?
NCT03491917 is a clinical study titled "Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer". The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
What is the current status of trial NCT03491917?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2017-11-03. Estimated completion is 2018-02-15.
What interventions are being tested in trial NCT03491917?
The interventions under investigation include: DBT plus S-View (DEVICE), FFDM alone (DEVICE).
Who is sponsoring clinical trial NCT03491917?
This trial is sponsored by Fujifilm Medical Systems USA, which has 13 total clinical trials registered on ClinicalTrials.gov.
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