A Proof-of-Concept Study Evaluating LINFU™
Completed · Not applicable
Conditions studied: Pancreas Adenocarcinoma, Dysplasia
In brief
The purpose of this research study is to study a method to detect pancreatic precancer and cancer (ductal adenocarcinoma) using ultrasound technology in those who are at significantly increased risk for developing pancreatic cancer. The LINFU™ Technique is done by analysis of pancreatic fluid collected with the help of ultrasound. This is an investigational way to detect pancreatic precancers and ductal adenocarcinoma.
Key facts
- Study ID
- NCT05161013
- Run by
- Adenocyte, LLC
- People needed
- 12
- Starts
- 2021-10-21
- Expected to finish
- 2023-10-30
- Last updated by the study team
- 2024-02-20
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Both males and females will be enrolled and must be at least 18 years of age and under age of 90
- Patients at high risk of developing a pancreatic malignancy.
- Patients undergoing EUS or receiving an MRI scan as part of their screening.
- Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
You may not qualify if…
- Patient under the age of 18 and over the age 90
- Patients undergoing FNA
- Contraindications to EUS as determined by study investigators.
- Patient with uncorrectable coagulopathy
- Patient that cannot undergo anesthesia due to cardio- pulmonary contraindication as deemed by the anesthesiologist
- 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 Lumason or Secretin
- Patients with an elevated baseline lipase level
Where it is running
- Gastroenterology Associates of Sarasota — Sarasota, Florida, United States
Full record on ClinicalTrials.gov
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