Contrast-Enhanced Ultrasound for Identifying Breast Masses

Recruiting at 1 trial location

Overseen By Janet Jaime

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Southern California

Disqualifiers: Pulmonary hypertension, Pregnant, Neoadjuvant chemotherapy, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial investigates the role of contrast enhanced ultrasound (CEUS) in identifying cystic breast masses as benign or malignant. Ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using radiation (x-rays). Ultrasounds are widely used to diagnose many diseases in the body. This trial may help researchers learn if using CEUS will help in determining whether or not an ultrasound guided biopsy is necessary.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are undergoing neoadjuvant chemotherapy, you cannot participate in the trial.

What data supports the effectiveness of the drug Perflutren Lipid Microspheres for identifying breast masses?

Research shows that microbubble contrast agents, like Perflutren Lipid Microspheres, enhance ultrasound imaging, which can help in distinguishing between benign and malignant breast lesions. This is supported by studies using similar agents, such as Sonazoid, which have shown improved diagnostic accuracy in breast cancer evaluation. ^{1 2 3 4 5}

How does contrast-enhanced ultrasound differ from other treatments for identifying breast masses?

Contrast-enhanced ultrasound (CEUS) using Sonazoid (perflubutane) is unique because it enhances ultrasound images to help differentiate between benign and malignant breast lesions, offering a non-invasive alternative to traditional methods like MRI. This approach can provide real-time imaging and potentially predict the malignancy grade of breast cancer, which is not typically possible with standard ultrasound. ^{1 4 6 7 8}

Research Team

Bino A Varghese, PhD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for individuals with breast masses that need to be checked if they're benign (not cancer) or malignant (cancer). It's not specified who can't join, but typically those with allergies to the contrast agents used or certain health conditions may be excluded.

Inclusion Criteria

I am 18 years old or older.

My breast mass is suspicious and needs a biopsy.

I am female.

Exclusion Criteria

I am a woman currently receiving chemotherapy before surgery.

I am allergic to perflutren.

I am a woman under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Patients receive a contrast agent intravenously and undergo CEUS scan over 60-90 minutes

1 day

1 visit (in-person)

Analysis

Development and assessment of radiomics-based ML classifier framework and TIC analysis

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging

4 weeks

Treatment Details

Interventions

• Perflutren Lipid Microspheres
• Sulfur Hexafluoride Lipid Microspheres

Trial Overview The study is testing whether a special type of ultrasound called CEUS, using Sulfur Hexafluoride and Perflutren Lipid Microspheres as contrast agents, can help tell apart non-cancerous from cancerous breast lumps without needing a biopsy.

Participant Groups

Group I: Diagnostic (contrast agent, CEUS) Experimental Treatment 3 Interventions

Patients receive a contrast tracer (Lumason or DEFINITY) IV and then undergo CEUS scan over 60-90 minutes.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Contrast-enhanced ultrasound (CEUS) using Sonazoid significantly improved the accuracy of diagnosing focal breast lesions compared to unenhanced ultrasound, with an accuracy rate of 87.2% versus 65.5%.

CEUS also demonstrated higher specificity than both unenhanced ultrasound and contrast-enhanced MRI, while maintaining a low incidence of mild adverse reactions (3.3%), indicating it is a safe and effective diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of sonazoid (perflubutane) for contrast-enhanced ultrasound in the differentiation of focal breast lesions: phase 3 multicenter clinical trial. Miyamoto, Y., Ito, T., Takada, E., et al.[2016]

The use of a new microbubble contrast agent in ultrasound significantly improved the ability to differentiate between cancerous and benign breast masses, with 100% sensitivity and specificity achieved after its administration.

Increased and prolonged Doppler signal enhancement was observed in cancerous lesions compared to benign ones, indicating that the contrast agent enhances the visualization of vascular features associated with tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbubble contrast agent for color Doppler US: effect on breast masses. Work in progress. Kedar, RP., Cosgrove, D., McCready, VR., et al.[2016]

In a study of 50 patients with locally advanced breast carcinoma, the use of Levovist contrast medium during color-Doppler ultrasound significantly increased the detection of vascular signals in 94% of lesions, indicating enhanced imaging capabilities.

The enhanced sensitivity of color-Doppler ultrasound with Levovist not only improved the assessment of neoplastic tissue but also correlated with postoperative histopathological findings, making it a valuable tool for evaluating the effectiveness of neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Color-doppler using contrast medium in evaluating the response to neoadjuvant treatment in patients with locally advanced breast carcinoma. Vallone, P., D'Angelo, R., Filice, S., et al.[2005]

In a study of 100 patients with invasive breast cancer, perfusion parameters from contrast-enhanced ultrasonography were found to be significantly higher in estrogen receptor-negative tumors compared to positive ones, indicating a potential link between these parameters and tumor biology.

The study demonstrated that variations in peak intensity of Ki-67, a marker of cell proliferation, were strongly correlated with perfusion parameters, suggesting that these imaging techniques could effectively predict high-grade malignancy and inform treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Malignancy Grade of Breast Cancer Using Perflubutane-Enhanced Ultrasonography. Masumoto, N., Kadoya, T., Amioka, A., et al.[2017]

Micro-bubble contrast agents, specifically perflutren lipid microspheres (Definity), were successfully used to visualize the bile duct in a pig model, allowing for clear imaging down to very small ducts (<2 mm).

This technique could enhance real-time imaging of the biliary system, potentially benefiting procedures like living donor liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a micro-bubble contrast agent to allow visualization of the biliary tree. Roberts, JP., Neill, A., Goldstein, R.[2016]

Contrast-enhanced ultrasound (CEUS) demonstrated high sensitivity (88%) and specificity (82%) in distinguishing between benign and malignant breast lesions, based on a systematic review of 51 studies involving 4875 patients.

CEUS also effectively predicted the pathologic response to neoadjuvant chemotherapy in breast cancer patients, with a sensitivity of 89% and specificity of 83%, indicating its potential as a reliable imaging tool in breast cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Contrast-Enhanced Ultrasound in the Diagnosis and Pathologic Response Prediction in Breast Cancer: A Meta-analysis and Systematic Review. Zhou, SC., Le, J., Zhou, J., et al.[2021]

In a study of 38 breast masses (22 malignant and 16 benign), the use of the contrast agent Levovist with power Doppler ultrasound (PDUS) and color Doppler ultrasound (CDUS) improved the detection of vascular structures, helping to differentiate between malignant and benign lesions.

Malignant lesions exhibited higher vascularity, with significant parameters identified as Vmax > 15 cm/sec and RI > 0.80 for CDUS, and RI > 0.70 for PDUS, indicating that these measurements can aid in reducing unnecessary surgeries by accurately identifying cancerous masses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contrast enhanced power Doppler and color Doppler ultrasound in breast masses: Efficiency in diagnosis and contributions to differential diagnosis]. Algül, A., Balci, P., Seçil, M., et al.[2019]

In a study of 72 women with suspected breast lesions, the use of contrast agents during color Doppler ultrasound significantly improved the ability to differentiate between benign and malignant tumors, with 78.1% of malignant tumors showing a hypervascularity pattern.

The contrast agents enhanced the sensitivity and negative predictive value of ultrasound signals, indicating that they can provide more accurate diagnoses compared to standard ultrasound alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of breast lesions using Doppler with contrast agents. Martínez, AM., Medina, CJ., Bustos, C., et al.[2020]

References

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

Efficacy of sonazoid (perflubutane) for contrast-enhanced ultrasound in the differentiation of focal breast lesions: phase 3 multicenter clinical trial. [2016]

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

Microbubble contrast agent for color Doppler US: effect on breast masses. Work in progress. [2016]

3. Greece pubmed.ncbi.nlm.nih.gov

Color-doppler using contrast medium in evaluating the response to neoadjuvant treatment in patients with locally advanced breast carcinoma. [2005]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of Malignancy Grade of Breast Cancer Using Perflubutane-Enhanced Ultrasonography. [2017]

5. Denmark pubmed.ncbi.nlm.nih.gov

The use of a micro-bubble contrast agent to allow visualization of the biliary tree. [2016]

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

The Role of Contrast-Enhanced Ultrasound in the Diagnosis and Pathologic Response Prediction in Breast Cancer: A Meta-analysis and Systematic Review. [2021]

7. Turkey pubmed.ncbi.nlm.nih.gov

[Contrast enhanced power Doppler and color Doppler ultrasound in breast masses: Efficiency in diagnosis and contributions to differential diagnosis]. [2019]

8. Singapore pubmed.ncbi.nlm.nih.gov

Assessment of breast lesions using Doppler with contrast agents. [2020]