The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

NCT06276764 | Enrolling By Invitation

• 1 other identifier: Adenocyte 103
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Conditions

IPMN, Pancreatic; Pancreas Cancer; Pancreatic Cyst

Outcome Measures

Primary Outcomes (1)

• The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods

  The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT

  5 years

Secondary Outcomes (2)

• The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period

  5 years

• Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention.

  5 years

Other Outcomes (1)

• Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU®

  5 years

Study Arms (1)

Patients with a documented history of IPMN

Patients with a documented history of IPMN by any imaging method will undergo the LINFU® procedure.

Diagnostic Test: LINFU®

Interventions

LINFU® DIAGNOSTIC_TEST

Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes. A contrast agent will be administered IV at five minute intervals. The patient will then receive a dose of secretin and the the patient's pancreatic juice will then be collected for a total of 15 minutes.

Patients with a documented history of IPMN

Eligibility Criteria

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

Study Population

Patients with a documented history of IPMN by any imaging method.

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 with a documented history of IPMN by any imaging method.
• All patients must undergo contemporaneous imaging (within 90 days before or after the LINFU® procedure) with one or more of the following: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
• Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure
• 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
• Contraindications to LINFU® as determined by study investigators:
• Patient with uncorrectable coagulopathy
• Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
• Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
• Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure
• Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
• Pregnant females will be excluded
• Patient that is unable to provide informed consent
• Patient with known allergy to the microbubble contrast agent or secretin
• Study Design Overview:

Sponsors & Collaborators

• Adenocyte, LLC: lead

Study Sites (1)

Manhattan Endoscopy Center

New York, New York, 10007, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Slides and cell blocks made from pancreatic fluid collected

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms; Pancreatic Neoplasms; Pancreatic Cyst

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Study Officials

• Gregory Haber, MD FRCP

  Manhattan Endoscopy Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): September 30, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)