Clinical trial NCT06276764: The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
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)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: IPMN, Pancreatic
Pancreas Cancer
Pancreatic Cyst
Lead sponsor: Adenocyte, LLC
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a documented history of IPMN by any imaging method.

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.

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

Eligibility criteria: 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 with a documented history of IPMN by any imaging method.
3. 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
4. Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure
5. 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. Contraindications to LINFU® as determined by study investigators:

   1. Patient with uncorrectable coagulopathy
   2. Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
   3. Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
3. Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure
4. Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
5. Pregnant females will be excluded
6. Patient that is unable to provide informed consent
7. Patient with known allergy to the microbubble contrast agent or secretin

Study Design Overview:

Primary outcomes:
measure: The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
Other outcomes:
measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU®
timeFrame: 5 years
Locations:
city: New York
country: United States
facility: Manhattan Endoscopy Center
state: New York
Study officials:
affiliation: Manhattan Endoscopy Center
name: Gregory Haber, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: