3-D Super Resolution Ultrasound Microvascular Imaging

NCT04136912 | Terminated Phase 2 Results DMC FDA Drug FDA Device

• 2 other identifiers: LCCC1915R01CA220681
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Thyroid Cancer

Keywords

Cancer Screening

Outcome Measures

Primary Outcomes (4)

• Sensitivity of Acoustic Angiography; Breast Imaging

  The sensitivity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity (%) = True Positives (TP)+False Negatives (FN)True Positives (TP)

  Baseline

• Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans)

  Specificity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity was calculated based on the formula, which is true negative / (true negative + false positive).

  Baseline

• 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. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available.

  Baseline

• Specificity of Acoustic Angiography; Thyroid Imaging (Percent of Negative Scans)

  Specificity of Acoustic Angiography in the analysis of known thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available.

  Baseline

Secondary Outcomes (6)

• Area Under the Curve of Acoustic Angiography (Arbitrary Units)

  Baseline

• Radiologist Preference (Arbitrary Units)

  Baseline

• Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units)

  Baseline

• Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units)

  Baseline

• Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units)

  Baseline

Study Arms (3)

Breast Imaging Cohort

EXPERIMENTAL

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

Drug: Definity; Device: Acoustic Angiography

Thyroid Imaging Cohort

EXPERIMENTAL

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

Drug: Definity; Device: Acoustic Angiography

Healthy Volunteers Cohort

EXPERIMENTAL

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

Drug: Definity; Device: Acoustic Angiography

Interventions

Definity 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.

Also known as: perflutren

Breast Imaging Cohort; Healthy Volunteers Cohort; Thyroid Imaging Cohort

Acoustic Angiography 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.

Breast Imaging Cohort; Healthy Volunteers Cohort; Thyroid Imaging Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Univeristy of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Thyroid Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Desma Jones
• Organization: UNC Lineberger Comprehensive Cancer Center

desma_jones@med.unc.edu

(919) 843-9463

Study Officials

• Yueh Lee, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: May 26, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 6, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• 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.

Locations

US (1)