Acoustic Angiography for Breast Cancer

Overseen By Carly Sronce

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

27 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have active cardiac disease or are critically ill, you may not be eligible to participate.

What data supports the effectiveness of the treatment Acoustic Angiography for breast cancer?

Acoustic angiography, a type of ultrasound imaging, has shown promise in identifying abnormal blood vessel patterns associated with tumors, which can help in detecting and evaluating breast cancer. Studies have demonstrated its ability to create detailed images of blood vessels in and around tumors, potentially aiding in distinguishing between benign and malignant lesions. ^{1 2 3 4 5}

Is acoustic angiography safe for humans?

Initial studies of acoustic angiography in humans, specifically imaging the hand, wrist, and breast, have been conducted using healthy volunteers, suggesting it is safe for human use. However, these studies are preliminary, and more research is needed to fully understand its safety profile. ^{2 3 6 7 8}

How does acoustic angiography differ from other breast cancer treatments?

Acoustic angiography is unique because it uses a contrast-enhanced ultrasound technique to create detailed 3-D maps of the blood vessels in and around breast tumors, helping to identify cancerous growths by their abnormal blood vessel patterns. Unlike traditional methods, it does not use ionizing radiation, potentially reducing unnecessary biopsies by providing more specific imaging of breast lesions. ^{1 2 3 5 9}

Research Team

Yueh Lee, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Inclusion Criteria

You have a mammogram result with a score of 4 or 5.

The patient had a breast ultrasound study done at UNC.

The patient received a thyroid ultrasound study at UNC.

Exclusion Criteria

I am not critically ill or medically unstable.

I do not have severe heart problems like recent heart attacks or unstable angina.

My breast lump is larger than 2cm or deeper than 3cm from the skin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Optimization

Healthy volunteers undergo imaging to optimize parameters for acoustic angiography

4 weeks

1 visit (in-person)

Diagnostic Imaging

Participants with breast and thyroid lesions undergo acoustic angiography and b-mode ultrasound prior to scheduled biopsy

6 months

1 visit (in-person) per participant

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

Treatment Details

Interventions

• Acoustic Angiography

Trial Overview 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.

Participant Groups

Group I: Thyroid Imaging Cohort Experimental Treatment 2 Interventions

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

Group II: Healthy Volunteers Cohort Experimental Treatment 2 Interventions

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

Group III: Breast Imaging Cohort Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Photoacoustic imaging has advanced significantly over the past 25 years, showing promise for non-invasive breast cancer detection through various imaging technologies and strategies.

Most clinical studies conducted so far are primarily proof-of-principle demonstrations, indicating that while the technology is promising, further research is needed for its full clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future trends in photoacoustic breast imaging. Manohar, S., Dantuma, M.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Quantification of Microvascular Tortuosity during Tumor Evolution Using Acoustic Angiography. [2018]

2. England pubmed.ncbi.nlm.nih.gov

First-in-Human Study of Acoustic Angiography in the Breast and Peripheral Vasculature. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Visualization of Microvascular Angiogenesis Using Dual-Frequency Contrast-Enhanced Acoustic Angiography: A Review. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[The prognostic value of angiogenic activity evaluation with contrast enhanced power doppler imaging in axillary-node-negative breast carcinoma]. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

An optoacoustic imaging feature set to characterise blood vessels surrounding benign and malignant breast lesions. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Acoustic angiography: a new imaging modality for assessing microvasculature architecture. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Development of a digital breast phantom for photoacoustic computed tomography. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Current and future trends in photoacoustic breast imaging. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Photoacoustic image patterns of breast carcinoma and comparisons with Magnetic Resonance Imaging and vascular stained histopathology. [2022]