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

Launched by ADENOCYTE, LLC · Feb 18, 2024

Keywords

ClinConnect Summary

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 use...

Gender

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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: