Clinical trial NCT04136912: 3-D Super Resolution Ultrasound Microvascular Imaging
Official title: High Frame Rate 3-D Super Resolution Ultrasound Microvascular Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Thyroid Cancer
Keywords: Cancer Screening
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-23
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensitivity of Acoustic Angiography; Breast Imaging (percent of positive scans)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Specificity of Acoustic Angiography; Breast Imaging (percent of negative scans)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Sensitivity of Acoustic Angiography; Thyroid Imaging (percent of positive scans)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Specificity of Acoustic Angiography; Thyroid Imaging (percent of negative scans)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary outcomes:
measure: Area Under the Curve of Acoustic Angiography (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Radiologist preference (Arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Sensitivity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Specificity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Sensitivity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Specificity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Univeristy of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yueh Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: