The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma (NCT06157671) | Clinical Trial Compass
By InvitationNot Applicable
The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma
United States1,000 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 range
18 Years – 90 Years
Sex
ALL
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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be compared to standard screening methods