Academic-Industrial Partnership for Translation of Acoustic Angiography

Phase 4

Completed

Brief 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.

Detailed Description: Increasing the sensitivity and specificity of diagnostic imaging in patients at high risk for breast cancer could provide substantial clinical benefit by improving diagnosis, preventing over-treatment, and reducing healthcare costs. Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density. It evaluates tumor micro-vasculature and may provide a powerful prognostic tool for the diagnosis of breast cancer, and eventually for treatment evaluation.

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. 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Acoustic Angiography	Acoustic Angiography	All clinical patients will be included in the experimental group.
Image Optimization	Acoustic Angiography	In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.
Acoustic Angiography	Definity	All clinical patients will be included in the experimental group.
Image Optimization	Definity	In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	2 years	To compare (using a reader study) the sensitivity and specificity of acoustic angiography to the sensitivity and specificity of conventional b-mode ultrasound in evaluation of breast lesions

Secondary Outcome Measures

Name	Time	Method
Model-based Malignancy Score (Arbitrary Units)	2 years	To compare the model-based malignancy score to the acoustic angiography reader study
Vessel Tortuosity (No Units)	2 years	To quantify vessel tortuosity metrics for the acoustic angiograph images, and to use these metrics to develop a model for predicting malignancy (a model-based malignancy score)
Area Under the Curve (AUC) of Acoustic Angiography	2 years	To compare the area under the curve (AUC) of acoustic angiography to the AUC of the b-mode ultrasound To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins, and vascularity) Primary Endpoint Sensitivity and specificity for our study is defined as the ability of readers (radiologists) to use the acoustic angiography or b-mode ultrasound to distinguish between malignant and non-malignant breast lesions known to exist based on pathological results (the gold standard). The AUC of acoustic angiography compared to the AUC of b-mode ultrasound
Radiologist Preference	2 years	To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity)