NCT04793633Enrolling by invitation
Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer
The LINFU® (A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into Pancreatic Fluid) U.S. Registry for the Detection of PanIn-2, PanIn-3, and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC)
Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 8 Mar 2021
- Start date
- 31 Jan 2024
- Primary completion date
- 30 Dec 2030
- Lead sponsor
- Adenocyte, LLC
- Diseases
- Pancreatic cancer
- NCT number
- NCT04793633
What you commit to
- Study type: Observational
- Planned participants: 500
- From 31 Jan 2024 to the primary completion date, 30 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
- Patient with known allergy to the microbubble contrast agent or secretin
Age
- Patient under the age of 18 and over the age 90
Other
- 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)
- Pregnant females will be excluded
- Patient that is unable to provide informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sarasota Memorial HealthCare System Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.