Clinical trial · Observational
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
A Retrospective, Observational, Case-controlled, Multi-reader, Multi-case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Breast Screening | — | UNRESOLVED | — |
| Benign Breast Findings | — | UNRESOLVED | — |
| Breast Cancer Detection | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Dense Breast Parenchyma | — | UNRESOLVED | — |
| Normal Breast Screening | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reading of Automated Breast Ultrasound in conjunction with Screening Mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- MRMC Analysis: ROC AUC
- timeFrame
- 8 Weeks
- description
- Area under the ROC curve (AUC)
Secondary outcomes (1)
- measure
- Sensitivity and Specificity
- timeFrame
- 8 Weeks
- description
- True Positive Rate and True Negative Rate
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following base Inclusion Criteria: * Hold a current United States medical license * Be American Board of Radiology Certified * Be MQSA-qualified * Be experienced in reading DM images on a monitor * Be experienced in reading Breast Ultrasound images on a monitor * Have completed a Financial Disclosure showing no Conflicts of Interest * Have provided a current curriculum vitae (CV) * Have provided a signed Readers' Agreement * Have provided written Informed Consent All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.
References
Publications (0)
Data not yet available