Last reviewed · How we verify
NCT03972605: DMT SV RRS2
Delphinus SoftVue™ ROC Reader Study
trial testing Reading of Automated Breast Ultrasound in conjunction with Screening Mammography in Breast Cancer Detection in 32 participants. Completed in 2 July 2019.
2 July 2019
Quick facts
| Lead sponsor | Delphinus Medical Technologies, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 32 |
| Start date | 8 June 2019 |
| Primary completion | 2 July 2019 |
| Estimated completion | 2 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
Conditions studied
- Breast Cancer Detection — all drugs for Breast Cancer Detection →
- Dense Breast Parenchyma — all drugs for Dense Breast Parenchyma →
- Benign Breast Findings — all drugs for Benign Breast Findings →
- Normal Breast Screening — all drugs for Normal Breast Screening →
Sponsor
Delphinus Medical Technologies, Inc.
Who can join
Eligibility, any sex, with Breast Cancer Detection or Dense Breast Parenchyma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 approximately 32 radiologist readers and a sample of approximately 200 breast screening cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phases B, C, and D. The reader study image case set will be enriched with cancer cases.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03972605
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
Trials testing the same drug.
- NCT04260620 — Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3) · completed
- NCT03698942 — Delphinus SoftVue™ ROC Reader Study · completed
Other recruiting trials for Breast Cancer Detection
Currently open trials in the same condition.
- NCT07331506 — Validation of the Oncoliq Test for the Early Detection of Breast Cancer. · recruiting
- NCT07214883 — UCF MammoChat: Image Repository · recruiting
- NCT07080515 — Developing Screening Clinical Breast Examination Implementation Strategies in Nigeria · recruiting
Other Delphinus Medical Technologies, Inc. trials
Trials by the same sponsor.
- NCT04260620 — Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3) · completed
- NCT03698942 — Delphinus SoftVue™ ROC Reader Study · completed
- NCT03257839 — Delphinus SoftVue Prospective Case Collection - ARM 1 · completed
- NCT02977247 — Delphinus SoftVue Prospective Case Collection - ARM 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03972605 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Delphinus Medical Technologies, Inc.
- Last refreshed: 28 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03972605.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing