Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection o… (NCT04793633) | Clinical Trial Compass
By InvitationNot Applicable
Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer
United States500 participantsStarted 2024-01-31
Plain-language 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 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).
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Both males and females will be enrolled and must be at least 18 years of age and under age of 90
âś“. 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
âś“. High risk asymptomatic patients being screened for PDAC
âś“. 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
âś“. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Exclusion criteria
âś•. Patient under the age of 18 and over the age 90
âś•. Contraindications to LINFU/EUS/ERCP as determined by study investigators:
âś•. Patient with uncorrectable coagulopathy
âś•. Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
What they're measuring
1
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor