Contrast Enhanced Ultrasound for Pancreatic Cancer

Overseen By Srinivas Gaddam, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Age <18, Pregnancy, Cardiopulmonary conditions, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 visit

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether quantitative contrast-enhanced endoscopic ultrasound (CE-EUS) improves the evaluation of pancreas tumors and precursor lesions, including cysts, compared to conventional endoscopic ultrasound.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment EUS Contrast Agent, Levovist, SonoVue, Sonazoid, Optison, Luminity, Albunex for pancreatic cancer?

Research shows that using contrast-enhanced ultrasound (a type of imaging test) with agents like SonoVue and Sonazoid can help in better imaging of the pancreas, which may aid in treatment planning. Additionally, a study on a similar technique called sonoporation showed improved survival in pancreatic cancer patients when combined with standard chemotherapy. ^{1 2 3 4 5}

Is contrast-enhanced ultrasound safe for humans?

Research on various contrast agents like Levovist, Optison, and others used in ultrasound shows they have been tested for safety in humans, often for heart and liver conditions. These studies generally indicate that these agents are safe, but specific side effects or risks can vary depending on the agent and individual health conditions. ^{1 5 6 7 8}

How is the EUS Contrast Agent treatment unique for pancreatic cancer?

The EUS Contrast Agent treatment for pancreatic cancer is unique because it uses microbubble contrast agents to enhance ultrasound imaging, allowing for better differentiation between types of pancreatic tumors and monitoring of treatment effects, which is not possible with standard imaging techniques. ^{1 3 5 9 10}

Research Team

Srinivas Gaddam, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for individuals who are undergoing endoscopic ultrasound due to unexplained pancreatitis, pancreatic masses, or cystic lesions. It's also open to those with concerning clinical signs, imaging results, or lab findings related to the pancreas.

Inclusion Criteria

I have unexplained pancreatitis or suspicious pancreatic findings.

I am scheduled for an endoscopic ultrasound for my pancreas.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic ultrasound (EUS) with IV contrast agent for research purposes

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through chart review or phone call

12 months

Chart review or phone call

Treatment Details

Interventions

• EUS Contrast Agent

Trial Overview The study tests if using a special dye (contrast) during an endoscopic ultrasound can better evaluate pancreatic tumors and precursor lesions like cysts compared to the usual method without contrast.

Participant Groups

Group I: Contrast EUS Experimental Treatment 1 Intervention

Undergoing EUS for pancreatic indication (cyst, pancreatitis, mass)

EUS Contrast Agent is already approved in European Union, Japan, United States for the following indications:

Approved in European Union as SonoVue for:

• Liver tumors
• Pancreatic tumors
• Gastrointestinal tumors

Approved in Japan as Sonazoid for:

• Liver tumors

Approved in United States as Optison for:

• Cardiovascular imaging

Approved in United States as Luminity for:

• Cardiovascular imaging

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

In a study involving 8 healthy Beagles, perfluorobutane (PFB) provided significantly better signal conspicuity and higher quantitative parameters (peak intensity, wash-in rate, and area under the curve) compared to sulfur hexafluoride microbubbles (SHM) during contrast-enhanced ultrasonography (CEUS) of the pancreas.

Both contrast agents produced similar homogeneity scores for pancreatic enhancement, but PFB demonstrated superior performance, indicating it may be the preferred choice for CEUS in dogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of sulfur hexafluoride microbubbles and perfluorobutane for performance of contrast-enhanced ultrasonography of the pancreas in dogs. Park, S., Je, H., Jang, S., et al.[2022]

The development of contrast-enhanced ultrasound image-guided drug delivery (CEUS-IGDD) has shown promising results in a Phase I clinical trial, significantly increasing median survival for patients with inoperable pancreatic ductal adenocarcinoma (PDAC) from 8.9 months to 17.6 months when combined with standard chemotherapy.

This innovative method, known as sonoporation, is being optimized for a larger Phase II clinical trial, highlighting its potential to improve treatment outcomes for patients with this challenging cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonoporation for Augmenting Chemotherapy of Pancreatic Ductal Adenocarcinoma. Castle, J., Kotopoulis, S., Forsberg, F.[2020]

Continuous infusion of the ultrasound contrast medium Levovist provides a significantly longer duration of contrast enhancement in patients with liver or pancreatic tumors compared to bolus injection, although the intensity of the enhancement is lower.

Using the injection valve of an intravenous cannula for Levovist administration results in suboptimal contrast enhancement, making it a less favorable option compared to direct bolus injection through the main channel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contrast enhanced power Doppler sonography: comparison of various administration forms of the ultrasound contrast agent Levovist]. Kratzer, W., Kächele, V., Merkle, E., et al.[2016]

Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) demonstrated a high sensitivity of 92% and an accuracy of approximately 82% in differentiating pancreatic adenocarcinomas from other pancreatic diseases in a study of 90 patients.

The study found a significant association between a hypoenhanced pattern on CH-EUS and pancreatic duct adenocarcinoma, suggesting that this imaging technique can be a valuable tool for diagnosis, especially when EUS-fine needle aspiration results are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of contrast-enhanced harmonic endoscopic ultrasound for the evaluation of solid pancreatic masses. Park, JS., Kim, HK., Bang, BW., et al.[2022]

Contrast-enhanced ultrasonography (CE-US) using the agent levovist effectively visualizes gallbladder lesions, including cancer, and can distinguish between different types of gallbladder diseases in 42 patients.

CE-US revealed various enhancement patterns in gallbladder cancer, with branched patterns potentially indicating malignancy, and it also provided insights into direct invasion to the liver and metastasis, highlighting its utility as a minimally invasive diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasonography in the diagnosis of gallbladder disease. Tsuji, S., Sofuni, A., Moriyasu, F., et al.[2019]

In a study of 203 patients, OPTISON significantly outperformed ALBUNEX in enhancing echocardiographic contrast, achieving better visualization of the left ventricular endocardial border and converting nondiagnostic echocardiograms to diagnostic ones more effectively.

Both contrast agents had similar safety profiles, with transient side effects, but OPTISON provided a longer duration of contrast enhancement, making it a superior choice for echocardiographic imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent. Results of a phase III Multicenter Trial. Cohen, JL., Cheirif, J., Segar, DS., et al.[2019]

The use of SHU508 A (Levovist) as a contrast agent during endoscopic ultrasonography (EUS) significantly enhances color Doppler signals, improving the visualization of blood vessels like the celiac artery and superior mesenteric artery in swine models.

This enhancement could lead to better diagnostic accuracy in EUS for conditions such as malignant vascular invasion and pancreatic neoplasms, indicating a promising role for SHU508 A in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced endoscopic ultrasonography with galactose microparticles: SHU508 A (Levovist). Bhutani, MS., Hoffman, BJ., van Velse, A., et al.[2016]

In a study of seven heavy drinkers with hypervascular liver nodules, contrast-enhanced ultrasound (CEUS) using Levovist effectively identified benign nodules by showing a characteristic ring-shaped appearance, which could help differentiate them from hepatocellular carcinoma (HCC).

While all nodules were diagnosed as HCC on contrast-enhanced computed tomography (CECT), pathological results revealed that three were benign, highlighting the importance of CEUS in providing accurate diagnoses in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ring-shaped appearance in liver-specific image with Levovist: a characteristic enhancement pattern for hypervascular benign nodule in the liver of heavy drinkers. Maruyama, H., Matsutani, S., Kondo, F., et al.[2016]

SonoVue demonstrated superior in vitro and in vivo contrast-enhanced ultrasound imaging performance compared to Optison, with a 2- to 10-fold higher normalized scattered power and longer duration of enhancement in the pig heart.

When compared to Definity, SonoVue showed similar or slightly better imaging performance, particularly in liver imaging, where both agents had comparable enhancement, but SonoVue outperformed Optison in both peak and duration of enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Echogenicity of Clinical Ultrasound Contrast Agents: An In Vitro and In Vivo Comparison Study. Hyvelin, JM., Gaud, E., Costa, M., et al.[2022]

Second-generation intravenous blood-pool ultrasound contrast agents enhance endoscopic ultrasound (EUS) by improving the characterization of microvascularization and aiding in the differential diagnosis of benign and malignant lesions, particularly in focal pancreatic masses.

Dynamic contrast-enhanced harmonic EUS is particularly promising for monitoring the effects of chemotherapy and anti-angiogenic therapy in advanced digestive cancers, offering advantages over traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced harmonic endoscopic ultrasound. Săftoiu, A., Dietrich, CF., Vilmann, P.[2016]

References

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

Comparison of sulfur hexafluoride microbubbles and perfluorobutane for performance of contrast-enhanced ultrasonography of the pancreas in dogs. [2022]

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

Sonoporation for Augmenting Chemotherapy of Pancreatic Ductal Adenocarcinoma. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

[Contrast enhanced power Doppler sonography: comparison of various administration forms of the ultrasound contrast agent Levovist]. [2016]

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

Effectiveness of contrast-enhanced harmonic endoscopic ultrasound for the evaluation of solid pancreatic masses. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasonography in the diagnosis of gallbladder disease. [2019]

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

Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent. Results of a phase III Multicenter Trial. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Contrast-enhanced endoscopic ultrasonography with galactose microparticles: SHU508 A (Levovist). [2016]

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

Ring-shaped appearance in liver-specific image with Levovist: a characteristic enhancement pattern for hypervascular benign nodule in the liver of heavy drinkers. [2016]

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

Characteristics and Echogenicity of Clinical Ultrasound Contrast Agents: An In Vitro and In Vivo Comparison Study. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Contrast-enhanced harmonic endoscopic ultrasound. [2016]