drugset / Trial / NCT03544268

Academic-Industrial Partnership for Translation of Acoustic Angiography

NCT03544268

Non-randomizedSequentialOpen-labelDiagnostic

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.

Timeline

Start
2019-03-25
Primary completion
2021-05-25
Completion
2021-05-25

Drugs

EvaluationDrugModalityDoseRoute
Background Definity Diagnostic / imaging agent Intravenous

Indications

No indication recorded.