The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma
Enrolling by invitation
Conditions studied: Pancreatic Adenocarcinoma, Pancreatic Intraepithelial Neoplasia
In brief
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).
Key facts
- Study ID
- NCT06157671
- Run by
- Adenocyte, LLC
- People needed
- 1000
- Starts
- 2024-01-31
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Manhattan Endoscopy Center — New York, New York, United States
Full record on ClinicalTrials.gov
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