Breast Cancer Clinical Trial
3-D Super Resolution Ultrasound Microvascular Imaging
Summary
This is a 3-arm single center study of 45 patients. These cohorts will include 15 breast patients scheduled to undergo a biopsy, and 15 thyroid patients scheduled to undergo fine needle aspiration, biopsy, or thyroidectomy that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy. Prior to imaging clinical patients, the third arm will include 15 healthy volunteers that will be imaged to optimize imaging parameters.
Full Description
Increasing the sensitivity and specificity of diagnostic imaging in patients at high risk for breast or thyroid 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.
Eligibility Criteria
Healthy Volunteers
Inclusion Criteria
Able to provide informed consent
Negative urine pregnancy test in women of child-bearing potential
Exclusion Criteria
Institutionalized subject (prisoner or nursing home patient)
Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
Known hypersensitivity to perflutren lipid (Definity®)
Active cardiac disease including any of the following:
Severe congestive heart failure
Unstable angina.
Severe arrhythmia
Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
Pulmonary hypertension
Cardiac shunts
Breast Imaging Patients
Inclusion Criteria
Women
Patient had a diagnostic breast ultrasound study performed at UNC
Scheduled for a core needle or surgical breast biopsy of at least one breast lesion that is 2 cm or less in size and 3 cm in depth from the skin surface
Able to provide informed consent
Negative urine pregnancy test in women of child-bearing potential
BIRADS score of 4 or 5.
Exclusion Criteria
Male
Institutionalized subject (prisoner or nursing home patient)
Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
Sonographically visible breast lesion larger than 2cm or greater than 3cm in depth from the skin surface
Known hypersensitivity to perflutren lipid (Definity®)
Active cardiac disease including any of the following:
Severe congestive heart failure
Unstable angina.
Severe arrhythmia
Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
Pulmonary hypertension
Cardiac shunts
Thyroid Imaging Patients Inclusion Criteria
Patient had a diagnostic thyroid ultrasound study performed at UNC
TIRADS risk score of 4c or 5
Scheduled for a core needle or surgical thyroid biopsy, fine needle aspiration, or thyroidectomy of at least one sonographically visible thyroid lesion that is 3 cm in depth from the skin surface
Able to provide informed consent
Negative urine pregnancy test in women of child-bearing potential
Exclusion Criteria
Institutionalized subject (prisoner or nursing home patient)
Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
Known hypersensitivity to perflutren lipid (Definity®)
Active cardiac disease including any of the following:
Severe congestive heart failure
Unstable angina.
Severe arrhythmia
Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
Pulmonary hypertension
Cardiac shunts
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There is 1 Location for this study
Chapel Hill North Carolina, 27599, United States More Info
Principal Investigator
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