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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up calculated once all imaging is complete [anticipated 1.5 years]
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
Definity
2007
Completed Phase 4
~520
Acoustic Angiography
2019
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,598 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,298 Patients Enrolled for Breast Cancer
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,126 Total Patients Enrolled
49 Trials studying Breast Cancer
27,819 Patients Enrolled for Breast Cancer
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for participants in this experiment?

"Accessing the clinicaltrials.gov portal, one can observe that this investigation into patient health is open for recruitment. The trial was published on May 26th 2022 and has been updated most recently on June 1st of the same year."

Answered by AI

How many participants has this research project recruited?

"Affirmative. Clinicaltrials.gov hosts information indicating that the trial, originally posted on May 26th 2022, is actively seeking participants. 45 individuals from 1 site are necessary for this medical research to be successful."

Answered by AI

What is the ultimate outcome that this clinical trial seeks to accomplish?

"The prime objective of this trial, with a planned duration of 1.5 years to complete all imaging, is to measure the Sensitivity of Acoustic Angiography; Breast Imaging (percentage-wise). Secondary outcomes encompass assessing the sensitivity and specificity of acoustic angiography against conventional ultrasound when employed in evaluating known breast lesions for malignancy prediction as well as thyroid lesion evaluation for cancer detection."

Answered by AI

Is Acoustic Angiography a risk-free procedure for individuals?

"After due consideration, Acoustic Angiography was rated a 2 on the safety scale since this is still a Phase 2 trial and there's only limited evidence for its efficacy."

Answered by AI

Could you elaborate on any other explorations of Acoustic Angiography?

"Presently, 19 clinical trials are underway regarding Acoustic Angiography. Among these studies, one is in its third phase of development. The majority of tests take place in Philadelphia but a total of 26 different sites have been allocated for study purposes."

Answered by AI

For what diseases is Acoustic Angiography commonly employed?

"Acoustic Angiography is the go-to modality for echocardiography, but its potential applications are much broader. Medical experts often use it to diagnose cardiovascular diseases and left ventricular imaging as well."

Answered by AI
~10 spots leftby Oct 2024