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NCT03501693 · ClinicalTrials.gov registry record
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
A clinical trial, sponsored by Fujifilm Medical Systems USA.
- Completed
- Registry status
- 300
- Enrollment target
NCT03501693: Completed study, sponsored by Fujifilm Medical Systems USA.
NCT03501693 is a clinical trial that has completed, run by Fujifilm Medical Systems USA. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03501693 has completed, sponsored by Fujifilm Medical Systems USA.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study 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.
Primary Outcome
Average of each radiologist reader's ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confi
Interventions
- DEVICE FFDM Alone
- DEVICE DBT plus S-View
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2018-04-06 |
| Est. Completion | 2018-08-31 |
What the finished NCT03501693 record still lists
NCT03501693 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which FFDM Alone is the first listed.
NCT03501693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03501693 about?
NCT03501693 is a clinical study titled "Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study". 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.
What is the current status of trial NCT03501693?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2018-04-06. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT03501693?
The interventions under investigation include: FFDM Alone (DEVICE), DBT plus S-View (DEVICE).
Who is sponsoring clinical trial NCT03501693?
This trial is sponsored by Fujifilm Medical Systems USA, which has 13 total clinical trials registered on ClinicalTrials.gov.
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