3-D Super Resolution Ultrasound Microvascular Imaging

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 3-arm single center study of 35 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 5 healthy volunteers that will be imaged to optimize imaging parameters.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

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.

• Uncontrolled high blood pressure

• 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.

• Uncontrolled high blood pressure

• 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

• 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.

• Uncontrolled high blood pressure

• Cardiac shunts