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NCT03698942 · ClinicalTrials.gov registry record
Delphinus SoftVue™ ROC Reader Study
A clinical trial, sponsored by Delphinus Medical Technologies.
- Completed
- Registry status
- 6
- Enrollment target
NCT03698942: Completed study, sponsored by Delphinus Medical Technologies.
NCT03698942 is a clinical trial that has completed, run by Delphinus Medical Technologies. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03698942 has completed, sponsored by Delphinus Medical Technologies.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
Study Summary
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies. This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.
Primary Outcome
Area under the ROC curve (AUC)
Interventions
- DEVICE Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-09-23 |
| Est. Completion | 2018-09-23 |
What the finished NCT03698942 record still lists
NCT03698942 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Reading of Automated Breast Ultrasound in conjunction with Screening Mammography is the first listed.
NCT03698942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03698942 about?
NCT03698942 is a clinical study titled "Delphinus SoftVue™ ROC Reader Study". The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information tha...
What is the current status of trial NCT03698942?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2018-09-23. Estimated completion is 2018-09-23.
What interventions are being tested in trial NCT03698942?
The interventions under investigation include: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography (DEVICE).
Who is sponsoring clinical trial NCT03698942?
This trial is sponsored by Delphinus Medical Technologies, which has 5 total clinical trials registered on ClinicalTrials.gov.
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