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Enrolling by invitation NCT06276764

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

— Observational IPMN, Pancreatic Pancreas Cancer Pancreatic Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LINFU®.
Who it may be relevant to
Registry conditions: IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The LINFU® U.S. Registry for the Detection of Dysplasia and Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

Overview

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.

Detailed description

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.

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) which are not identified with current diagnostic tests. In addition, patients identified with PDAC or precursor lesions only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes

Interventions

  • Diagnostic test LINFU®
    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.

Primary outcome measures

  • The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods [Time frame: 5 years]
Secondary outcome measures (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 [Time frame: 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. [Time frame: 5 years]

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 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.

Exclusion criteria

  • 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:

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Manhattan Endoscopy Center — New York

Identifiers

NCT: NCT06276764 · Adenocyte 103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗