Acoustic Angiography for Breast Cancer

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HM
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Overseen ByCarly Sronce
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique called Acoustic Angiography to determine if it can better detect breast and thyroid lesions. It includes three groups: one for breast patients, another for thyroid patients, and a group of healthy volunteers to refine the imaging process. The goal is to assess whether Acoustic Angiography combined with ultrasound can improve biopsy accuracy. Women with breast lesions or individuals with thyroid lesions already scheduled for a biopsy may be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in medical imaging.

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 prior data suggests that acoustic angiography is safe for breast and thyroid imaging?

Research has shown that acoustic angiography, a new method for imaging blood vessels using sound waves, has been tested for both breast and thyroid imaging. Previous studies report that this technology is generally well-tolerated, with no major safety issues.

For breast imaging, studies have found that it provides clear images without using radiation, making it safer than some traditional methods that do use radiation.

In thyroid imaging, acoustic angiography also appears safe. Although it's a new technique, research has not identified any serious side effects.

Being in a Phase 2 trial indicates the treatment has already passed initial safety tests. While monitoring for new information remains important, current studies suggest it is safe.12345

Why are researchers excited about this trial?

Researchers are excited about acoustic angiography for breast cancer because it offers a non-invasive imaging technique that could provide clearer, more detailed pictures of blood vessels in breast tissue. Unlike traditional imaging methods, like mammograms or MRIs, acoustic angiography uses sound waves to create high-resolution images, potentially improving the accuracy of breast cancer diagnoses. This technique could help doctors detect tumors earlier and tailor treatments more precisely, reducing unnecessary biopsies and improving patient outcomes.

What evidence suggests that acoustic angiography is effective for breast and thyroid imaging?

Research has shown that acoustic angiography, a new imaging method, could be promising for detecting breast cancer. This technique provides detailed pictures of blood vessels in breast tissue. In this trial, participants in the Breast Imaging Cohort will undergo acoustic angiography to assess its effectiveness compared to traditional methods like mammograms, which can sometimes miss tumors. For thyroid issues, participants in the Thyroid Imaging Cohort will be evaluated to see if acoustic angiography helps spot unusual growths more clearly. Early findings suggest it could improve detection without using radiation, a common concern with other imaging methods.15678

Who Is on the Research Team?

Yueh Z. Lee, MD, PhD, FACR | UNC ...

Yueh Lee, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.
See 5 more

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Thyroid Imaging CohortExperimental Treatment2 Interventions
Group II: Healthy Volunteers CohortExperimental Treatment2 Interventions
Group III: Breast Imaging CohortExperimental Treatment2 Interventions

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

A first in human study of acoustic angiography in the breast ...Screening with mammography has been demonstrated to increase breast cancer survival rates by about 20%. However, the current system in which mammography is ...
Advances in Photoacoustic Imaging of Breast Cancer - PMCBreast cancer screening is aimed to identify potential precancerous lesions in breast tissue through noninvasive, efficient, and sensitive ...
First-in-Human Study of Acoustic Angiography in the Breast ...Screening with mammography has been found to increase breast cancer survival rates by about 20%. However, the current system in which mammography is used to ...
Photoacoustic integrated multimodal imaging for breast ...As illustrated in Figure 5iii, PA imaging provides consistent intensity and vascular detail across various breast densities, outperforming X-ray ...
High-speed photoacoustic and ultrasonic computed ...This technology shows strong potential for early breast tumor diagnosis, offering enhanced accuracy without the need for ionizing radiation, ...
Acoustic Angiography and Ultrasound Imaging in ...This clinical trial studies how well acoustic angiography works in evaluating patients with breast lesions compared to traditional ultrasound imaging.
Photoacoustic imaging of breast cancer: a mini review of ...Photoacoustic (PA) imaging is an emerging modality that enables deep tissue imaging of optical contrast at ultrasonically defined spatial resolution.
An optoacoustic imaging feature set to characterise blood ...Our findings indicate that OA-US can reveal vascular patterns of breast lesions that indicate malignancy using a simple feature set based on single wavelength ...
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