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3-D Super Resolution Ultrasound Microvascular Imaging

Primary Purpose

Breast Cancer, Thyroid Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Definity

Acoustic Angiography

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Cancer Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Univeristy of North Carolina Chapel HillRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Breast Imaging Cohort

Thyroid Imaging Cohort

Healthy Volunteers Cohort

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Sensitivity of Acoustic Angiography; Breast Imaging (percent of positive scans)

Sensitivity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Specificity of Acoustic Angiography; Breast Imaging (percent of negative scans)

Specificity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Sensitivity of Acoustic Angiography; Thyroid Imaging (percent of positive scans)

Sensitivity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Specificity of Acoustic Angiography; Thyroid Imaging (percent of negative scans)

Specificity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Secondary Outcome Measures

Area Under the Curve of Acoustic Angiography (arbitrary units)

To compare the area under the curve (AUC) of acoustic angiography to the AUC of the b-mode ultrasound

Radiologist preference (Arbitrary units)

To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins, and vascularity)

Sensitivity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)

To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.

Specificity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)

To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.

Sensitivity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)

To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.

Specificity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)

To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.

Full Information

NCT ID

NCT04136912

First Posted

October 21, 2019

Last Updated

October 24, 2023

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04136912

Brief Title

3-D Super Resolution Ultrasound Microvascular Imaging

Official Title

High Frame Rate 3-D Super Resolution Ultrasound Microvascular Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 26, 2022 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Thyroid Cancer

Keywords

Cancer Screening

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Breast Imaging Cohort

Arm Type

Experimental

Arm Description

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

Arm Title

Thyroid Imaging Cohort

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy Volunteers Cohort

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Definity

Other Intervention Name(s)

perflutren

Intervention Description

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

Device

Intervention Name(s)

Acoustic Angiography

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sensitivity of Acoustic Angiography; Breast Imaging (percent of positive scans)

Description

Sensitivity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Specificity of Acoustic Angiography; Breast Imaging (percent of negative scans)

Description

Specificity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Sensitivity of Acoustic Angiography; Thyroid Imaging (percent of positive scans)

Description

Sensitivity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Specificity of Acoustic Angiography; Thyroid Imaging (percent of negative scans)

Description

Specificity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Secondary Outcome Measure Information:

Title

Area Under the Curve of Acoustic Angiography (arbitrary units)

Description

To compare the area under the curve (AUC) of acoustic angiography to the AUC of the b-mode ultrasound

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Radiologist preference (Arbitrary units)

Description

To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins, and vascularity)

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Sensitivity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)

Description

To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Specificity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)

Description

To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Sensitivity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)

Description

To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

Title

Specificity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)

Description

To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.

Time Frame

Calculated once all imaging is complete [Anticipated 1.5 years]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carly Sronce

Phone

9199663262

carly_sronce@med.unc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Desma Jones, CCRC

Phone

9198439463

desma_jones@med.unc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yueh Lee, MD, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

Univeristy of North Carolina Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carly Sronce

Phone

919-966-3262

carly_sronce@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Desma Jones, CCRC

Phone

9198439463

desma_jones@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Yueh Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified individual data that supports the results

IPD Sharing Time Frame

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.

IPD Sharing Access Criteria

An investigator who proposes to use the data must have approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Learn more about this trial

3-D Super Resolution Ultrasound Microvascular Imaging

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