Status:
TERMINATED
3-D Super Resolution Ultrasound Microvascular Imaging
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, bi...
Detailed 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 ove...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04136912
Start Date
May 26 2022
End Date
August 1 2024
Last Update
October 6 2025
Active Locations (1)
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1
Univeristy of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599