Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer

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 as well as those with 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 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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