3-D Super Resolution Ultrasound Microvascular Imaging

NCT ID: NCT04136912

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2024-08-01

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, 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.

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 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.

Conditions

Breast Cancer; Thyroid Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breast Imaging Cohort

A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy

Group Type: EXPERIMENTAL

Definity

Intervention Type: DRUG

Perflutren will be administered in split doses using the dosing range and administration type IV bolus) within the perflutren prescribing information. When administered as a bolus, the package insert recommends 10 uL/kg patient weight administered within 30-60 seconds, followed by a 10mL saline flush with a second dose of 10 uL/kg patient weight 30 minutes following the first dose, if needed.

Acoustic Angiography

Intervention Type: DEVICE

Acoustic angiography imaging involves a research ultrasound scanner 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. Imaging will be performed within the package insert guidelines for ultrasound system mechanical index (a measurement of output power) when imaging perflutren contrast agent (less than 0.8).

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.

Thyroid Imaging Cohort

A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy

Group Type: EXPERIMENTAL

Definity

Intervention Type: DRUG

Perflutren will be administered in split doses using the dosing range and administration type IV bolus) within the perflutren prescribing information. When administered as a bolus, the package insert recommends 10 uL/kg patient weight administered within 30-60 seconds, followed by a 10mL saline flush with a second dose of 10 uL/kg patient weight 30 minutes following the first dose, if needed.

Acoustic Angiography

Intervention Type: DEVICE

Acoustic angiography imaging involves a research ultrasound scanner 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. Imaging will be performed within the package insert guidelines for ultrasound system mechanical index (a measurement of output power) when imaging perflutren contrast agent (less than 0.8).

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.

Healthy Volunteers Cohort

A total of 15 participants will be included to optimize imaging parameters.

Group Type: EXPERIMENTAL

Definity

Intervention Type: DRUG

Perflutren will be administered in split doses using the dosing range and administration type IV bolus) within the perflutren prescribing information. When administered as a bolus, the package insert recommends 10 uL/kg patient weight administered within 30-60 seconds, followed by a 10mL saline flush with a second dose of 10 uL/kg patient weight 30 minutes following the first dose, if needed.

Acoustic Angiography

Intervention Type: DEVICE

Acoustic angiography imaging involves a research ultrasound scanner 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. Imaging will be performed within the package insert guidelines for ultrasound system mechanical index (a measurement of output power) when imaging perflutren contrast agent (less than 0.8).

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.

Interventions

Definity

Perflutren will be administered in split doses using the dosing range and administration type IV bolus) within the perflutren prescribing information. When administered as a bolus, the package insert recommends 10 uL/kg patient weight administered within 30-60 seconds, followed by a 10mL saline flush with a second dose of 10 uL/kg patient weight 30 minutes following the first dose, if needed.

Intervention Type: DRUG

Acoustic Angiography

Acoustic angiography imaging involves a research ultrasound scanner 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. Imaging will be performed within the package insert guidelines for ultrasound system mechanical index (a measurement of output power) when imaging perflutren contrast agent (less than 0.8).

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.

Intervention Type: DEVICE

Other Intervention Names

perflutren

Eligibility Criteria

Inclusion Criteria

• Able to provide informed consent
• Negative urine pregnancy test in women of child-bearing potential

• 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.

• 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

Breast Imaging Patients

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yueh Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Univeristy of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01CA220681

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC1915

Identifier Type: -

Identifier Source: org_study_id