A Proof-of-Concept Study Evaluating LINFU™
Condition: Pancreas Adenocarcinoma; Dysplasia
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      The purpose of this research study is to study a method to detect pancreatic precancer and
      cancer (ductal adenocarcinoma) using ultrasound technology in those who are at significantly
      increased risk for developing pancreatic cancer. The LINFU™ Technique is done by analysis of
      pancreatic fluid collected with the help of ultrasound. This is an investigational way to
      detect pancreatic precancers and ductal adenocarcinoma.
    

Detailed description: 
      Patients will undergo collection of pancreatic fluid by the LINFU™ Technique as part of this
      study. This procedure takes about 30-45 minutes. The details for the procedure are listed
      below.

      LINFU™ Technique

        1. 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.

        2. 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.

        3. 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.

        4. The participant will then undergo EGD (insertion of a tube down the throat and past the
           stomach). EGD stands for esophagogastroduodenoscopy. The Investigator who is doing EGD
           will discuss all risks and explain how the procedure will be done.

        5. The pancreatic juice will be collected immediately. About 15 minutes after the EGD
           procedure has begun, a second dose of secretin will be administered.

        6. The pancreatic juice will continue to be collected for a total of 30 minutes.

      The results of the LINFU technique will be provided to the investigator to help guide medical
      care. This is an experimental technique so participants won't receive the results.
      Participants will undergo clinical diagnostic procedures including EUS (endoscopic
      ultrasound) and/or MRI as part of the standard medical care and evaluation for pancreatic
      cancer. These procedures are not part of the study and the Investigator has already
      determined that these tests are required.

      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. In addition, participants
      will have blood tests before the LINFU procedure and this will be repeated 24hours after the
      procedure. The blood tests will measure lipase levels to make sure there was no injury to the
      pancreas.

      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.
    

Intervention name(s): LINFU™
Intervention type(s): Diagnostic Test
Intervention description(s): A method to detect pancreatic cancer (ductal adenocarcinoma) using ultrasound technology in those who are at significantly increased risk for developing pancreatic cancer. LINFU™ involves analysis of pancreatic fluid collected.
Intervention model: Single Group Assignment
Intervention model description: Patients at high risk of developing pancreatic cancer
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Pancreatic Neoplasm; Pancreatic Cancer; Early detection