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Acoustic Angiography for Breast Cancer

Phase 2
Recruiting
Led By Yueh Lee, MD, PhD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up calculated once all imaging is complete [anticipated 1.5 years]
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether acoustic angiography can help doctors better understand a patient's blood vessels before performing a biopsy.

Who is the study for?
This trial is for adults who can consent and are scheduled for certain breast or thyroid biopsies or surgeries at UNC. Women must not be pregnant. Excluded are those in critical condition, with severe heart issues, known allergies to Definity®, men, and anyone with larger or deeper lesions than specified.
What is being tested?
The study tests a new ultrasound technique called Acoustic Angiography combined with standard imaging on patients with breast or thyroid conditions before their biopsies/surgeries. It also includes healthy volunteers to fine-tune the imaging process.
What are the potential side effects?
Potential side effects may relate to the contrast agent Definity® used during ultrasound, which could include allergic reactions, changes in blood pressure, headache, nausea, and rare but serious cardiac events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a thyroid biopsy or surgery for a visible lesion.
Select...
I am scheduled for a breast biopsy of a small lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not critically ill or medically unstable.
Select...
I do not have severe heart problems like recent heart attacks or unstable angina.
Select...
My breast lump is larger than 2cm or deeper than 3cm from the skin.
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I am male.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~calculated once all imaging is complete [anticipated 1.5 years]
This trial's timeline: 3 weeks for screening, Varies for treatment, and calculated once all imaging is complete [anticipated 1.5 years] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity of Acoustic Angiography; Breast Imaging (percent of positive scans)
Sensitivity of Acoustic Angiography; Thyroid Imaging (percent of positive scans)
Specificity of Acoustic Angiography; Breast Imaging (percent of negative scans)
+1 more
Secondary study objectives
Area Under the Curve of Acoustic Angiography (arbitrary units)
Radiologist preference (Arbitrary units)
Sensitivity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Thyroid Imaging CohortExperimental Treatment2 Interventions
A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy
Group II: Healthy Volunteers CohortExperimental Treatment2 Interventions
A total of 15 participants will be included to optimize imaging parameters.
Group III: Breast Imaging CohortExperimental Treatment2 Interventions
A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acoustic Angiography
2019
Completed Phase 4
~50
Definity
2007
Completed Phase 4
~540

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,987 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
362 Previous Clinical Trials
91,941 Total Patients Enrolled
Yueh Lee, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

Acoustic Angiography Clinical Trial Eligibility Overview. Trial Name: NCT04136912 — Phase 2
~13 spots leftby Nov 2025
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