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

Summary

Participation Requirements

Description

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 li...

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.

Tracking Information