The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma

Pancreatic Adenocarcinoma Clinical Trial

Official title:

The LINFU® (A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into Pancreatic Fluid) U.S. Registry for the Detection of Low and High- Grade Atypia and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06157671
• Other study ID #: Adenocyte 101
• Status: Enrolling by invitation
• Start date: January 31, 2024
• Est. completion date: June 1, 2030

Study information

• Verified date: December 2023
• Source: Adenocyte, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions. The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis. Patients enrolled are being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes).

Description:

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) to increase the sensitivity of pancreatic juice cytology. LINFU® consists of analysis of pancreatic fluid collected with the help of low intensity non-focused ultrasound excitation of the pancreas. A contrast agent will be used to create bubbles and possibly increase the number of pancreatic cell we collect for the study. Secretin is also used to increase the number of pancreatic cell excretion to maximize the number of cells collected. A neural network-based computer-assisted system may be used to enhance the analysis of specimens.

In this registry, LINFU® will be studied in patients who are at increased risk for developing pancreatic cancer including those being screened because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes) and are undergoing other diagnostic tests (i.e. EUS- FNA, MRI/MRCP, ERCP, CT, CEUS).

In this registry, a standardized Case Report Form will be completed for every subject enrolled. Information obtained at baseline will include patient history, clinical and demographic information including relevant comorbidities and pancreatic disease history, and screening and pathology test results. The results of all diagnostic tests, surgeries, and biopsies performed after the LINFU® technique for a period of 5 years will be recorded and maintained as clinical registry data. This includes testing and procedures received since enrollment including EUS- FNA, MRI/MRCP, ERCP, CT, CEUS, treatments performed, pathology results, and pancreatic disease history since enrollment.

The registry case report form is the primary data collection instrument for the registry. All data requested on the form must be recorded and these forms will be monitored carefully by the sponsor to ensure they are completely filled out properly.

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Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: June 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria

• Both males and females will be enrolled and must be at least 18 years of age under age of 90

• Patients who, in the opinion of the Investigator, are at elevated risk of developing a pancreatic malignancy because they have known risk factors for PDAC.

• High risk asymptomatic patients being screened for PDAC.

• All patients must undergo contemporaneous imaging (within 90 days of LINFU®) 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 including:

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 with clinical signs or symptoms of PDAC

• Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium

• Patients with documented intraductal papillary mucinous neoplasm of the pancreas (IPMN)

• Pregnant females will be excluded

• Patient that is unable to provide informed consent

• Patient with known allergy to the microbubble contrast agent or secretin

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Locations

Country	Name	City	State
United States	Manhattan Endoscopy Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Adenocyte, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU®	Patients will be followed by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS and yearly survival rates of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be recorded.	5 years
Primary	The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be compared to standard screening methods	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- FNA, MRI/MRCP, ERCP, CT and CEUS.	5 years
Secondary	The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period.	Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions 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
Secondary	Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention.	Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions 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 how many require medical or surgical intervention.	5 years