Clinical trial · Observational
Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer
The LINFU® (A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into Pancreatic Fluid) U.S. Registry for the Detection of PanIn-2, PanIn-3, 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 (1)
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 Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LINFU™ Technique | Combination Product | — | UNRESOLVED |
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) or have signs or symptoms of disease and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer
- interventionNames
- Combination Product: LINFU™ Technique
Primary outcomes (1)
- measure
- The number of pancreatic ductal adenocarcinomas and their noninvasive precursor
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Both males and females will be enrolled and must be at least 18 years of age and under age of 90 2. 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 or signs or symptoms of PDAC 3. High risk asymptomatic patients being screened for PDAC 4. Patients with clinical signs or symptoms of PDAC including abnormal imaging and who are scheduled for EUS- FNA, MRI/MRCP, ERCP, or CT will be enrolled 5. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study. Exclusion Criteria 1. Patient under the age of 18 and over the age 90 2. Contraindications to LINFU/EUS/ERCP as determined by study investigators: 1. Patient with uncorrectable coagulopathy 2. Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist 3. Unstable medically (cardiopulmonary, neurologic, or cardiovascular status) 3. Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium 4. Pregnant females will be excluded 5. Patient that is unable to provide informed consent 6. Patient with known allergy to the microbubble contrast agent or secretin
References
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