The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pa… (NCT06276764) | Clinical Trial Compass
By InvitationNot Applicable
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
United States500 participantsStarted 2024-10-15
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
âś“. Both males and females will be enrolled and must be at least 18 years of age and under age of 90
âś“. 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
âś“. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Exclusion criteria
âś•. Patient under the age of 18 and over the age 90
✕. Contraindications to LINFU® as determined by study investigators:
âś•. Patient with uncorrectable coagulopathy
âś•. Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
âś•. Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
âś•. Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure
âś•. Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
What they're measuring
1
The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods