Contrast-Enhanced Ultrasound for Breast Cancer

Overseen By Kibo Nam, MD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Thomas Jefferson University

Disqualifiers: Pregnancy, Medically unstable, Cardiac arrhythmias, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to measure tissue pressure in breast cancer patients using an advanced ultrasound technique called contrast-enhanced ultrasound (CEUS). The goal is to determine if CEUS can measure tissue pressure without invasive procedures. It targets patients scheduled for a breast biopsy with a mass of at least 1 cm. Participants must be medically stable and able to comply with study requirements. This approach could potentially simplify and improve breast cancer diagnosis. As an Early Phase 1 trial, the research focuses on understanding how this new ultrasound technique functions in people, offering participants a chance to contribute to groundbreaking advancements in breast cancer diagnosis.

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. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that contrast-enhanced ultrasound is safe for breast cancer patients?

Research has shown that contrast-enhanced ultrasound (CEUS) is a safe method in medical imaging, particularly for diagnosing breast cancer. In past studies, CEUS helped doctors see important details about breast tumors. This method uses a contrast agent called Definity, administered through an IV.

Specific safety data for CEUS in this trial is not yet available, but Definity is commonly used in similar imaging techniques and is generally well-tolerated by patients. Minor reactions, such as warmth or pain at the IV site, may occur, but serious side effects are rare.

This study is in an early phase, aiming to gather more information on safety and effectiveness. Its progression to this stage suggests some confidence in its safety for human use. However, ongoing research will provide clearer insights. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Contrast-Enhanced Ultrasound (CEUS) for breast cancer because it offers a non-invasive diagnostic technique with enhanced imaging capabilities. Unlike traditional mammograms or standard ultrasounds, CEUS uses a special contrast agent called Definity, which is delivered intravenously. This agent improves the clarity and detail of ultrasound images, allowing for better visualization of blood flow and tissue structures within the breast. This could potentially lead to more accurate diagnoses and reduce the need for more invasive procedures like biopsies.

What evidence suggests that contrast-enhanced ultrasound is effective for estimating tissue pressure in breast cancer?

Research has shown that contrast-enhanced ultrasound (CEUS), which participants in this trial will undergo, is useful for diagnosing breast cancer. It clarifies images by highlighting the difference between blood vessels in tumors and the surrounding tissue. This aids in identifying new blood vessel growth in tumors, a common feature of cancer. Studies have found that CEUS can help doctors distinguish between benign (non-cancerous) and malignant (cancerous) breast tumors, potentially reducing the need for unnecessary biopsies. Overall, CEUS shows promise in improving breast cancer diagnosis and management. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 21 with breast cancer who are medically stable and have a mass in the breast suitable for biopsy. They must be able to follow study procedures, not be pregnant or nursing, and have no severe illnesses or recent surgeries.

Inclusion Criteria

Provide signed and dated informed consent form

I am at least 21 years old.

Be medically stable as determined by the investigator

Exclusion Criteria

I am not pregnant or nursing.

I am not critically ill, on life support, or have unstable heart or lung conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Patients undergo ultrasound without contrast, receive Definity IV over 15 minutes, and undergo CEUS

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contrast-Enhanced Ultrasound
• Perflutren Lipid Microcpheres
• Ultrasonography

Trial Overview The trial studies how well contrast-enhanced ultrasound can estimate tissue pressure in the breast noninvasively. It involves using an ultrasound with a special contrast agent called Perflutren Lipid Microspheres.

How Is the Trial Designed?

Group I: Diagnostic (CEUS) Experimental Treatment 3 Interventions

Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.

Contrast-Enhanced Ultrasound is already approved in European Union, United States for the following indications:

Approved in European Union as CEUS for:

• Diagnosis of renal cell carcinoma
• Monitoring of recurrent renal cell carcinoma

Approved in United States as CEUS for:

• Diagnosis of renal cell carcinoma
• Monitoring of recurrent renal cell carcinoma

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4919761/

Contrast-enhanced ultrasound improved performance of ... CONCLUSION: This pilot study suggests that evaluation of BI-RADS 4 breast lesions with CEUS results in reduced biopsy rates and increased cancer-to-biopsy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7912589/

Contrast-Enhanced Ultrasonography in the Diagnosis and ... The aim of this paper is to highlight the role of contrast-enhanced ultrasound in breast cancer in terms of diagnosis, staging and follow-up ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526820923002896

Contrast-Enhanced Ultrasound and Conventional ... By enhancing image contrast between tumor blood vessels and surrounding tissues, consequently ultrasound contrast agents can visualize tumor neovascularization.

4. link.springer.com link.springer.com/article/10.1007/s10396-024-01486-0

Current status and future perspectives of contrast ... CEUS proves beneficial in various aspects of breast cancer management, including differential diagnosis of breast lesions, assessment of tumor ...

5. cancerimagingjournal.biomedcentral.com cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-023-00539-w

The diagnostic value of contrast-enhanced ultrasonography in ... Recently, contrast-enhanced ultrasound (CEUS) was proven to be an effective way of differentiating benign from malignant breast tumors [16,17,18] ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X24001074

Predictive value of contrast-enhanced ultrasonography and ... This finding suggests that CEUS may offer greater benefits in improving risk assessment and diagnostic accuracy for this specific subgroup of breast masses.