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

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

NCT ID: NCT06276764

Condition: IPMN, Pancreatic
Pancreas Cancer
Pancreatic Cyst

Conditions: Official terms:
Neoplasms
Pancreatic Neoplasms
Pancreatic Cyst
Neoplasms, Cystic, Mucinous, and Serous
Pancreatic Intraductal Neoplasms

Study type: Observational [Patient Registry]

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: LINFU®
Description: 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.
Arm group label: Patients with a documented history of IPMN

Intervention type: Diagnostic Test
Intervention name: Standard imaging tests
Description: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
Arm group label: Patients with a documented history of IPMN

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

Criteria for eligibility:

Study pop:
Patients with a documented history of IPMN by any imaging method.

Sampling method: Non-Probability Sample
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:

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: September 15, 2024

Completion date: December 1, 2034

Lead sponsor:
Agency: Adenocyte, LLC
Agency class: Industry

Source: Adenocyte, LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06276764