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NCT04260620 · ClinicalTrials.gov registry record
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
A clinical trial of Breast Cancer Detection and Dense Breast Parenchyma, sponsored by Delphinus Medical Technologies.
- Completed
- Registry status
- 32
- Enrollment target
- 1
- Study location
NCT04260620: Completed study of Breast Cancer Detection and Dense Breast Parenchyma, sponsored by Delphinus Medical Technologies.
NCT04260620 is a study of Breast Cancer Detection and Dense Breast Parenchyma that has completed, run by Delphinus Medical Technologies. The registered enrollment target is 32 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04260620, a study of Breast Cancer Detection and Dense Breast Parenchyma, has completed, sponsored by Delphinus Medical Technologies.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
- 1
- Study location
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 reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.
Primary Outcome
Area under the ROC curve (AUC)
Conditions Studied
Interventions
- DEVICE Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
Study Locations (1)
Michigan
- Delphinus Medical Technologies, Inc. - Novi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-02-08 |
| Est. Completion | 2020-03-03 |
What the finished NCT04260620 record still lists
NCT04260620 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 5 conditions, with Breast Cancer Detection appearing as the primary indexed condition, and to 1 intervention - of which Reading of Automated Breast Ultrasound in conjunction with Screening Mammography is the first listed.
NCT04260620 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04260620 about?
NCT04260620 is a clinical study titled "Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)". 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 reader study will include up to 3...
What is the current status of trial NCT04260620?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2020-02-08. Estimated completion is 2020-03-03.
What conditions does trial NCT04260620 study?
This clinical trial studies the following conditions: Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening, Abnormal Breast Screening.
What interventions are being tested in trial NCT04260620?
The interventions under investigation include: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography (DEVICE).
Who is sponsoring clinical trial NCT04260620?
This trial is sponsored by Delphinus Medical Technologies, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04260620 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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