A Proof-of-Concept Study Evaluating LINFU™

NCT05161013 | Completed FDA Device

• 1 other identifier: Adenocyte 111
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Adenocarcinoma; Dysplasia

Keywords

Pancreatic Neoplasm; Pancreatic Cancer; Early detection

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Study Arms (1)

The LINFU™ test

EXPERIMENTAL

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.

Diagnostic Test: LINFU™

Interventions

LINFU™ DIAGNOSTIC_TEST

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.

The LINFU™ test

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Adenocyte, LLC: lead

Study Sites (1)

Gastroenterology Associates of Sarasota

Sarasota, Florida, 34239, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Scott Corbett, MD, FASGE

  Suncoast Endoscopy of Sarasota (a division of Florida Digestive Health Specialists)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients at high risk of developing pancreatic cancer

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 16, 2021
• Study Start: October 21, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)