3-D Super Resolution Ultrasound Microvascular Imaging

UNC Lineberger Comprehensive Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Thyroid Cancer

Treatments: Device: Acoustic Angiography; Drug: Definity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04136912

R01CA220681 (U.S. NIH Grant/Contract)

LCCC1915

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Breast Imaging Cohort

Experimental group

Description:

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

Treatment:

Drug: Definity

Device: Acoustic Angiography

Thyroid Imaging Cohort

Experimental group

Description:

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

Treatment:

Drug: Definity

Device: Acoustic Angiography

Healthy Volunteers Cohort

Experimental group

Description:

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

Treatment:

Drug: Definity

Device: Acoustic Angiography