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Patients with a documented history of IPMN by any imaging method will undergo the LINFU® procedure.

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.

LINFU®

Standard imaging tests

Stephanie Lazarus

Gregory Haber, MD FRCP

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.

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

Slides and cell blocks made from pancreatic fluid collected

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

The LINFU® U.S. Registry for the Detection of Dysplasia and Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

Patients will be followed by EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT 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.

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

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, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT to assess whether these tumors increase in size (measured in mm) and to determine how many 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, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT to assess whether these tumors increase how many require medical or surgical intervention.

Adenocyte, LLC

Carcinoma

In this study, LINFU® will be evaluated to help identify pancreatic intraepithelial neoplasia-2 (PanIn-2), pancreatic intraepithelial neoplasia-3 (PanIn-3), and early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) in patients with no risk factors and who do not display signs or symptoms of pancreatic disease.

Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes using a GE LOGIQ10 or other FDA approved, FDA cleared or FDA exempt ultrasound insonation. A contrast agent will be administered IV during the ultrasound insonation and the patient will also receive a dose of secretin. The pancreatic juice will then be collected for a total of 15 minutes.

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.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3).

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 with no risk factors and who exhibit no signs or symptoms of disease. 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. 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 endoscopic ultrasound-fine-needle aspiration (EUS- FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP), computed tomography (CT), contrast-enhanced ultrasound (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.

The LINFU® U.S. Registry for the in the General Population Without Risk Factors

The LINFU® U.S. Registry for the Detection of Low and High-Grade Atypia and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC) in the General Population Without Risk Factors

Patients will be followed by standard imaging studies (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 with LINFU® will be recorded.

The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions (PanIn-2, PanIn-3) identified with LINFU® by analysis of pancreatic fluid will be recorded.

Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® 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.

Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be monitored long- term (5 years) by standard imaging studies (EUS- FNA, MRI/MRCP, ERCP, CT and CEUS) to assess whether these tumors increase and to determine how many require medical or surgical intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)	NCT06276764	IPMN, Pancreati... Pancreas Cancer Pancreatic Cyst	LINFU® Standard imagin...	18 Years - 90 Years	Adenocyte, LLC
The LINFU® U.S. Registry for the in the General Population Without Risk Factors	NCT06276803	Pancreatic Canc... Pancreatic Duct... Pancreatic Dysp...	LINFU®	18 Years - 90 Years	Adenocyte, LLC

Spots Global Cancer Trial Database for linfu®

Every month we try and update this database with for linfu® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for linfu®

Every month we try and update this database with for linfu® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for linfu® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.