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NCT03544268 · ClinicalTrials.gov registry record · Phase 4
Academic-Industrial Partnership for Translation of Acoustic Angiography
A Phase 4 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT03544268 is a Phase 4 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 20 participants.
The verdict
NCT03544268, a Phase 4 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Purpose: The primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound, and comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics. Participants: Sixty patients who are to have a clinical surgical breast biopsy based on results from pre-study standard of care (SOC) imaging will be recruited from the UNC Breast Clinic for participation in the study. Procedures (methods): This is a one arm single center study of patients with suspicious breast lesions (BIRADS 4 or 5) from the UNC Breast Clinic that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy.
Interventions
- DRUG Definity
- DEVICE Acoustic Angiography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2021-05-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03544268
The ClinicalTrials.gov registry entry for NCT03544268 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Definity is the first listed.
NCT03544268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03544268 about?
NCT03544268 is a clinical study titled "Academic-Industrial Partnership for Translation of Acoustic Angiography". Purpose: The primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for a...
What is the current status of trial NCT03544268?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2019-03-25. Estimated completion is 2021-05-25.
What interventions are being tested in trial NCT03544268?
The interventions under investigation include: Definity (DRUG), Acoustic Angiography (DEVICE).
Who is sponsoring clinical trial NCT03544268?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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