The LINFU® U.S. Registry for the in the General Population Without Risk Factors (NCT06276803) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The LINFU® U.S. Registry for the in the General Population Without Risk Factors
500 participantsStarted 2024-09-15
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.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3).
Who can participate
Age range18 Years – 90 Years
SexALL
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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, do not exhibit any symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc.
âś“. Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC
âś“. Patients, who in the opinion of the Investigator, should not be ordinarily screened for PDAC because they do not have risk factors including chronic pancreatitis, family history of PDAC, or genetic cancer syndromes which increase the risk of developing PDAC
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
✕. 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
âś•. Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
âś•. Patients, who in the opinion of the Investigator, are at risk of PDAC because they exhibit any of the following: clinical symptoms of PDAC, imaging abnormalities suggestive of PDAC, genetic syndromes which increase the risk of PDAC, a first degree relative with a history of pancreatic cancer, excessive exposure to dry-cleaning and metalworking chemicals
What they're measuring
1
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU®
Timeframe: 5 years
2
The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term