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)
The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods — 5 years The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
Trial sites (1)
Facility
City
Region
Status
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.
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