The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease

The LINFU® U.S. Registry for the Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With Clinical Signs and/or Symptoms of Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer; Abdominal Neoplasm; Jaundice
• Intervention / Treatment: Diagnostic test: LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas)

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Stephanie Lazarus; Phone Number: 9142632030; Email: slazarus@adenocyte.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

High risk patients with either clinical symptoms or imaging abnormalities or both, being evaluated for PDAC.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients at increased risk for developing pancreatic cancer; 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 will undergo LINFU® testing.

Diagnostic test: LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods	The total number of pancreatic ductal adenocarcinomas identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including endoscopic ultrasound ± fine needle aspiration (EUS± FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP),computed tomography (CT) or contrast-enhanced ultrasound (CEUS).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined	Patients with pancreatic ductal adenocarcinomas identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention.	5 years
Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention	Patients with pancreatic ductal adenocarcinomas identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase and how many require medical or surgical intervention.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU®	Patients will be followed by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS and yearly survival rates of patients with pancreatic ductal adenocarcinomas identified only with LINFU® and not detected with other diagnostic tests will be recorded.	5 years

Collaborators and Investigators

• Sponsor: Adenocyte, LLC
• Investigators: Principal Investigator: Gregory Haber, Manhattan Endoscopy Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): May 1, 2034

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Skin Manifestations; Hyperbilirubinemia; Abdominal Neoplasms; Jaundice; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: Adenocyte 102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No