Status:
ENROLLING_BY_INVITATION
The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma
Lead Sponsor:
Adenocyte, LLC
Conditions:
Pancreatic Adenocarcinoma
Pancreatic Intraepithelial Neoplasia
Eligibility:
All Genders
18-90 years
Brief Summary
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 lesi...
Detailed Description
Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) to increase the sensitivity of pancreatic juice cyto...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06157671
Start Date
January 31 2024
End Date
June 1 2030
Last Update
March 7 2025
Active Locations (1)
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1
Manhattan Endoscopy Center
New York, New York, United States, 10017