Diseases and Abnormalities at or Before Birth

All Conditions

Immune System Diseases

Congenital Abnormalities

Hypersensitivity

All breast patients will be included in the experimental group.

A volunteer group was added to the study to perfect the image acquisition techniques.

Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.

Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient.

Acoustic Angiography

Yueh Lee, MD, PhD

Purpose: This study will evaluate a new ultrasound imaging technology called acoustic angiography. Acoustic angiography uses an ultrasound contrast agent, already FDA approved for use in cardiology, to enhance imaging of blood vessels. Since acoustic angiography uses ultrasound, and not x-rays, the patient is not exposed to ionizing radiation, unlike traditional angiography and mammography. Specific goals will be to evaluate the quality of the images provided by acoustic angiography in the human breast, and furthermore to evaluate whether or not acoustic angiography provides additional diagnostic information over traditional ultrasound which could provide an improvement in assessing breast lesions. Specifically, this additional diagnostic information will hopefully enable us to reduce false positive tests and discriminate lethal cancers from non-lethal disease.

Participants: The investigators are recruiting 60 patients from the UNC Breast Clinic who are undergoing core needle biopsy or surgical biopsy (BIRADS 4 and 5 breast lesions).

Procedures (methods): Acoustic Angiography imaging will be performed in conjunction with standard diagnostic imaging, including b-mode ultrasound . Then, a reader study will be conducted to compare these modalities. Finally, the images will be analyzed with image processing techniques to determine quantitative metrics exhibited by the blood vessel morphology in the images. These metrics will be utilized to develop a "malignancy score" equation to predict malignancy of a lesion.

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, comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics, and quantification of vessel tortuosity based on acoustic angiography imaging results. These metrics will be used to develop a predictive model of malignancy which will subsequently be compared to results from radiology review.

Comparison of the Sensitivity and Specificity of Acoustic Angiography to the Sensitivity and Specificity of Conventional Ultrasound

Comparison of the Sensitivity and Specificity of Acoustic Angiography (Micro-tumor Detection by Quantifying Tumor-induced Vascular Abnormalities) to the Sensitivity and Specificity of Conventional Ultrasound

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

The AUC of acoustic angiography compared to the AUC of b-mode ultrasound

To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity)

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)

To compare the model-based malignancy score to the acoustic angiography reader study

National Cancer Institute (NCI)

UNC Lineberger Comprehensive Cancer Center

All breast patients will be included in the experimental group.

Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.

Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient.

A volunteer group was added to the study to perfect the image acquisition techniques.

Acoustic Angiography: Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.

Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient.

Healthy Volunteers

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Associate Director of Clinical Research Operations, Department of Radiology

The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature.

Sensitivity and Specificity (Percentage)

Area Under the Curve (AUC) of Acoustic Angiography

Preference Study not conducted because the imaging resolution was insufficient. The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature.

Spots Global Cancer Trial Database for acoustic angiography