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A Proof-of-Concept Study Evaluating LINFU™

Primary Purpose

Pancreas Adenocarcinoma, Dysplasia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LINFU™
Sponsored by
Adenocyte, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pancreas Adenocarcinoma focused on measuring Pancreatic Neoplasm, Pancreatic Cancer, Early detection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  1. Both males and females will be enrolled and must be at least 18 years of age and under age of 90
  2. Patients at high risk of developing a pancreatic malignancy.
  3. Patients undergoing EUS or receiving an MRI scan as part of their screening.
  4. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Exclusion criteria

  1. Patient under the age of 18 and over the age 90
  2. Patients undergoing FNA
  3. Contraindications to EUS as determined by study investigators.

    1. Patient with uncorrectable coagulopathy
    2. Patient that cannot undergo anesthesia due to cardio- pulmonary contraindication as deemed by the anesthesiologist
  4. Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
  5. Pregnant females will be excluded.
  6. Patient that is unable to provide informed consent
  7. Patient with known allergy to Lumason or Secretin
  8. Patients with an elevated baseline lipase level

Sites / Locations

  • Gastroenterology Associates of Sarasota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The LINFU™ test

Arm Description

LINFU™ to increase sensitivity of pancreatic juice cytology 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.

Outcomes

Primary Outcome Measures

Does LINFU™ yield an adequate number of cells that can be used to help diagnose pancreatic precancers and cancers?
The cells obtained from all 10 patients undergoing LINFU™ will be analyzed microscopically and counted by a pathologist for adequacy of pancreatic cellular yield. For a LINFU test to be considered adequate, 100 well-preserved ductal cells per patient must be counted under the microscope. Cellularity of >50 or <100 cells per patient would be interpreted as "limited but adequate" and cellularity <50 cells is unsatisfactory for adequacy.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2021
Last Updated
August 29, 2022
Sponsor
Adenocyte, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05161013
Brief Title
A Proof-of-Concept Study Evaluating LINFU™
Official Title
A Proof-of-Concept Study Evaluating LINFU™: A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into the Pancreatic Fluid for the Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adenocyte, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Adenocarcinoma, Dysplasia
Keywords
Pancreatic Neoplasm, Pancreatic Cancer, Early detection

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients at high risk of developing pancreatic cancer
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The LINFU™ test
Arm Type
Experimental
Arm Description
LINFU™ to increase sensitivity of pancreatic juice cytology 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
LINFU™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Does LINFU™ yield an adequate number of cells that can be used to help diagnose pancreatic precancers and cancers?
Description
The cells obtained from all 10 patients undergoing LINFU™ will be analyzed microscopically and counted by a pathologist for adequacy of pancreatic cellular yield. For a LINFU test to be considered adequate, 100 well-preserved ductal cells per patient must be counted under the microscope. Cellularity of >50 or <100 cells per patient would be interpreted as "limited but adequate" and cellularity <50 cells is unsatisfactory for adequacy.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Both males and females will be enrolled and must be at least 18 years of age and under age of 90 Patients at high risk of developing a pancreatic malignancy. Patients undergoing EUS or receiving an MRI scan as part of their screening. 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 Patients undergoing FNA 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 Patients with an elevated baseline lipase level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Corbett, MD, FASGE
Organizational Affiliation
Suncoast Endoscopy of Sarasota (a division of Florida Digestive Health Specialists)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology Associates of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Proof-of-Concept Study Evaluating LINFU™

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