Academic-Industrial Partnership for Translation of Acoustic Angiography
Status:
Completed
Trial end date:
2021-05-25
Target enrollment:
Participant gender:
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.