NCT06157671
The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma
Enrolling by Invitation
Not specifiedAges 18–90ObservationalAdenocyte, LLC
~1,000 participants
Updated 2025-03-07 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be compared to standard screening methods
Measured over 5 years
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Gregory Haber, MD FRCP · PRINCIPAL_INVESTIGATOR · Manhattan Endoscopy Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
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
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
What this trial measures
- The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be compared to standard screening methods5 years
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.