Clinical trial NCT06276738: The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease
Official title: The LINFU® U.S. Registry for the Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With Clinical Signs and/or Symptoms of Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer
Jaundice
Abdominal Neoplasm
Lead sponsor: Adenocyte, LLC
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk patients with either clinical symptoms or imaging abnormalities or both, being evaluated for PDAC.

Brief summary: Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.

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 exhibit symptoms suggestive of PDAC (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) or have evidence of imaging studies suggestive of PDAC. In addition, patients with PDAC identified only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and to determine whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Both males and females will be enrolled and must be at least 18 years of age and under age of 90
* Patients, who in the opinion of the Investigator, require biopsy to rule out PDAC because they display at least one of the following or both: a) clinical symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc. b) one or more imaging studies suggestive of PDAC
* All patients must undergo contemporaneous imaging, either within 90 days before the LINFU® procedure or within 30 days after the procedure, with one or more of the following: EUS± FNA, MRI/MRCP, ERCP, CT or CEUS.
* Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Exclusion Criteria:

* Patient under the age of 18 and over the age 90
* Contraindications to LINFU®/EUS/ERCP 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 undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
* Patients who are already known to have PDAC by cytologic or histologic evidence
* Patients with intraductal papillary mucinous neoplasm of the pancreas (IPMN) identified either before the study or during the study through imaging evaluation will be excluded
* Pregnant females will be excluded
* Patient that is unable to provide informed consent
* Patient with known allergy to the microbubble contrast agent or secretin

Primary outcomes:
measure: The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods
timeFrame: 5 years
Secondary outcomes:
measure: The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined
timeFrame: 5 years
measure: Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention
timeFrame: 5 years
Other outcomes:
measure: Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU®
timeFrame: 5 years
Locations:
Study officials:
affiliation: Manhattan Endoscopy Center
name: Gregory Haber
role: PRINCIPAL_INVESTIGATOR
References: