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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special ultrasound method to better evaluate pancreas issues, such as tumors or cysts, compared to the standard method. It uses a contrast agent (EUS Contrast Agent) to create clearer images of the pancreas during the ultrasound. Suitable candidates include those needing an endoscopic ultrasound for unexplained pancreatitis, pancreas masses, or cysts. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that this contrast-enhanced ultrasound is safe for evaluating pancreatic tumors?

Research has shown that using contrast-enhanced ultrasound (CE-EUS) to examine the pancreas has been promising. Studies have evaluated its effectiveness in identifying unusual areas in the pancreas, known as lesions.

Regarding safety, the contrast agent used in these studies is generally well-tolerated, with most people experiencing no problems. Few reports of serious side effects suggest it is relatively safe. However, individual experiences may vary.

For those considering joining a trial using this contrast agent, these findings might offer some reassurance. Since this trial is in an early stage, more safety information is still being collected. Discuss any questions or concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for pancreatic cancer focus on surgery, chemotherapy, or radiation. But the EUS Contrast Agent offers something different. Researchers are excited about this method because it uses contrast-enhanced ultrasound, a technique that could improve imaging clarity and accuracy. This advanced imaging helps doctors better identify and target pancreatic issues like cysts, pancreatitis, and masses. By providing clearer images, this technique could lead to more precise diagnoses and potentially better treatment outcomes.

What evidence suggests that this contrast-enhanced ultrasound is effective for evaluating pancreatic cancer?

Research has shown that contrast-enhanced endoscopic ultrasound (CE-EUS) provides superior images for examining pancreatic diseases. In this trial, participants will undergo CE-EUS with a contrast agent to enhance imaging. Studies have found that CE-EUS offers clear pictures, aiding doctors in viewing pancreatic tumors and cysts more distinctly. This improved imaging is crucial for accurate diagnosis. Enhanced ultrasound is especially useful for detecting changes in cyst walls, which might indicate early signs of cancer. Although these findings are promising, further research is needed to fully understand the benefits of CE-EUS. ^{1 2 6 7 8}

Who Is on the Research Team?

Srinivas Gaddam, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Contrast Enhanced Endoscopic Ultrasound in Pancreas ... The study is a prospective trial of CE- EUS in which the conventional EUS that is part of standard clinical care is conducted after injection of intravenous ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9222168/

Efficacy of Contrast-Enhanced Endoscopic ... Endoscopic ultrasound can be useful for obtaining detailed diagnostic images for pancreatic disease. Contrast-enhanced harmonic endoscopic ...

3. withpower.com withpower.com/trial/phase-1-pancreatitis-1-2020-89da7

Contrast Enhanced Ultrasound for Pancreatic Cancer The purpose of this study is to determine whether quantitative contrast-enhanced endoscopic ultrasound (CE-EUS) improves the evaluation of pancreas tumors and ...

4. bmjopengastro.bmj.com bmjopengastro.bmj.com/content/12/1/e001893

Endoscopic ultrasound for pancreatic cystic lesions EUS-nCLE enables real-time microscopic imaging of cyst walls, aiding in the detection of mucinous features and dysplasia. Guideline ...

5. ghadvances.org ghadvances.org/article/S2772-5723(24)00191-2/fulltext

Short-Term Outcomes of Endoscopic Ultrasound-Guided ... The combined analysis of the studies included in our review revealed that EUS-PCA exhibits substantial effectiveness in the treatment of pancreatic cystic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7232396/

Endoscopic ultrasound (EUS) and the management of ... This review aims to highlight the diagnostic and therapeutic role of EUS in the management of patients with pancreatic malignancy, especially pancreatic ductal ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01315548

Contrast Enhanced Harmonic Endoscopic Ultrasound ... The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of pancreatic focal lesions visualized by contrast-enhanced harmonic ...

8. cghjournal.org cghjournal.org/article/S1542-3565(10)00385-X/pdf

Contrast Harmonic Echo–Endoscopic Ultrasound Improves ... RESULTS: The finding of a hypoenhancing mass with an inhomogeneous pattern was a sensitive and accurate identifier of patients with adenocarci- noma (96% and 82 ...