Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this research study is to develop a method to detect pancreatic cancer (ductal adenocarcinoma) using ultrasound technology. It is called the LINFU™ Technique and done by analysis of pancreatic fluid collected with the help of ultrasound. This is an investigational way to detect pancreatic ductal adenocarcinoma. The results of this procedure will not be used to guide medical care.

Detailed Description
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Patients will undergo collection of pancreatic fluid by the LINFU™ Technique as part of this study. This procedure takes about 30-45 minutes. This procedure will be done in the beginning of the participant's standard of care endoscopic ultrasound procedure (EUS). The details for the procedure are listed below. LINFU™ Technique Once the participant is sedated or under anesthesia, low intensity non-focused ultrasound excitation of the pancreas will be implemented. This means the sound waves from the ultrasound on the top of the stomach will be used to stimulate the pancreas to release juice. During the ultrasound, the Investigator will administer Lumason through a vein in the participant's arm (IV). Lumason is a contrast agent that was frequently used to create bubbles that allows a better visualization of images. In this study, Lumason will be used to create bubbles and possibly increase the number of pancreatic cells collected for the study. After 25 minutes of ultrasound, the participant will receive an IV dose of secretin over 1 minute. Naturally, secretin is a hormone released into the bloodstream by a part of the small intestine, namely duodenum, (especially in response to acidity) to stimulate secretion by the liver and pancreas. In this study, Secretin is used to increase the number of pancreatic cell excretion to maximize the number of cells collected. The participant will then undergo clinically indicated EGD (insertion of a tube down the throat and past the stomach). EGD stands for esophagogastroduodenoscopy. This procedure would be done regardless of participating in the study. The Investigator who is doing EGD will discuss all risks and explain how the procedure will be done. The pancreatic juice will be collected immediately. About 15 minutes after the EGD procedure has begun, a second dose of secretin will be administered. The pancreatic juice will continue to be collected for a total of 30 minutes. The participant will then continue with the standard evaluation of the suspected malignancy with endoscopic ultrasound, with or without fine-needle aspiration (FNA). This is not part of the study and the Investigator has already determined that this test is required. The LINFU technique won't be used to guide medical care. This is an experimental technique so participants won't receive the results. Participants will undergo clinical diagnostic procedures as part of the standard medical care. Participants will be called 24 hours after the study procedure and 30 days after the procedure to see if any symptoms of pancreatitis (inflammation of the pancreas have developed). If so, participants will be asked to come back to the clinic for further evaluation as would be done as part of the standard medical care. Any identifiable private information or specimens collected and/or used for the purposes of this research will not be used or distributed for future research studies.

Official Title
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Evaluating LINFU™: A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into the Pancreatic Fluid for the Early Detection Pancreatic Ductal Adenocarcinoma (PDAC)

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Combination Product: LINFU™ Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both males and females will be enrolled and must be at least 18 years of age and under age of 90 Patients with a suspected pancreatic malignancy based upon clinical presentation and/or imaging findings. Patients undergoing EUS/FNA for suspected pancreatic malignancy. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study. Exclusion Criteria Patient under the age of 18 and over the age 90 Contraindications to EUS as determined by study investigators. Patient with uncorrectable coagulopathy Patient that cannot undergo anesthesia due to cardio- pulmonary contraindication as deemed by the anesthesiologist Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium Pregnant females will be excluded. Patient that is unable to provide informed consent Patient with known allergy to Lumason or Secretin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with suspected malignancy undergoing routine endoscopic ultrasound
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LINFU™ to increase sensitivity of pancreatic juice cytology<br>LINFU™ consists of analysis of pancreatic fluid collected with the help of low intensity non-focused ultrasound excitation of the pancreas. Lumason, will be used to create bubbles and possibly increase the number of pancreatic cell we collect for the study. Secretin is also used to increase the number of pancreatic cell excretion to maximize the number of cells collected. | Combination Product: LINFU™ Technique<br>* Non-focused ultrasound excitation of the pancreas with IV Lumason and IV secretin injected during the ultrasound procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can LINFU™ be used to help diagnose pancreatic precancers and cancers? | To determine if LINFU™ results in a robust number of ductal cells exfoliated from the exocrine pancreas that can be used to help diagnose pancreatic precancers and cancers. Patients: The pancreatic fluid collected will be analyzed at Adenocyte to determine if if LINFU™ results in a robust number of ductal cells exfoliated from the exocrine pancreas that can be used to help diagnose pancreatic precancers and cancers. | Up to 12 months |