Status:
ENROLLING_BY_INVITATION
Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer
Lead Sponsor:
Adenocyte, LLC
Conditions:
Pancreatic Ductal Adenocarcinoma
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 and 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 or signs or symptoms of PDAC
- High risk asymptomatic patients being screened for PDAC
- 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
- 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
- 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 :
December 30 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04793633
Start Date
January 31 2024
End Date
December 30 2030
Last Update
March 12 2024
Active Locations (1)
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1
Sarasota Memorial HealthCare System
Sarasota, Florida, United States, 34239