Clinical trial · Observational
The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Intraepithelial Neoplasia | Pancreatic Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients at increased risk for developing pancreatic cancer
- description
- Patients 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) and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer
Primary outcomes (1)
- measure
- The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be compared to standard screening methods
- timeFrame
- 5 years
- description
- 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.
Secondary outcomes (2)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available