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

Enrolling by invitation

Conditions studied: IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst

In brief

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.

Key facts

Study ID

NCT06276764

Run by

Adenocyte, LLC

People needed

500

Starts

2024-10-15

Expected to finish

2034-12-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

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:

Where it is running

• Manhattan Endoscopy Center — New York, New York, United States

Full record on ClinicalTrials.gov

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