Clinical trial · Observational
The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease
The LINFU® U.S. Registry for the Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With Clinical Signs and/or Symptoms of Disease
NCT06276738CI-TRIAL-00077139not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm | — | UNRESOLVED | — |
| Jaundice | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients at increased risk for developing pancreatic cancer
- description
- Patients who exhibit symptoms suggestive of PDAC (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) or have evidence of imaging studies suggestive of PDAC will undergo LINFU® testing.
- interventionNames
- Diagnostic Test: LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas)
Primary outcomes (1)
- measure
- The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods
- timeFrame
- 5 years
- description
- The total number of pancreatic ductal adenocarcinomas identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including endoscopic ultrasound ± fine needle aspiration (EUS± FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP),computed tomography (CT) or contrast-enhanced ultrasound (CEUS).
Secondary outcomes (2)
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 and under age of 90 * Patients, who in the opinion of the Investigator, require biopsy to rule out PDAC because they display at least one of the following or both: a) clinical symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc. b) one or more imaging studies suggestive of PDAC * All patients must undergo contemporaneous imaging, either within 90 days before the LINFU® procedure or within 30 days after the procedure, 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: 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 undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium * Patients who are already known to have PDAC by cytologic or histologic evidence * Patients with intraductal papillary mucinous neoplasm of the pancreas (IPMN) identified either before the study or during the study through imaging evaluation will be excluded * 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
No reference posted for this study.