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Clinical Trials in the USA / NCT06276764
Enrolling by invitation Observational

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

NCT06276764 · tracked via the Priya Life Science USA tracker
Sponsor
Adenocyte, LLC
Phase
Observational
Started
2024-10-15
Last updated
2026-08-06

Condition(s) studied

IPMN, PancreaticPancreas CancerPancreatic Cyst

Investigational drug(s) / intervention(s)

LINFU®

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Manhattan Endoscopy Center New York New York
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06276764 on ClinicalTrials.gov ↗ ← All trials in the USA