Pancreas Adenocarcinoma Clinical Trial
Official title:
A Proof-of-Concept Study Evaluating LINFU™: A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into the Pancreatic Fluid for the Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC)
Verified date | November 2023 |
Source | Adenocyte, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion criteria 1. Both males and females will be enrolled and must be at least 18 years of age and under age of 90 2. Patients at high risk of developing a pancreatic malignancy. 3. Patients undergoing EUS or receiving an MRI scan as part of their screening. 4. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study. Exclusion criteria 1. Patient under the age of 18 and over the age 90 2. Patients undergoing FNA 3. Contraindications to EUS as determined by study investigators. 1. Patient with uncorrectable coagulopathy 2. Patient that cannot undergo anesthesia due to cardio- pulmonary contraindication as deemed by the anesthesiologist 4. Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium 5. Pregnant females will be excluded. 6. Patient that is unable to provide informed consent 7. Patient with known allergy to Lumason or Secretin 8. Patients with an elevated baseline lipase level |
Country | Name | City | State |
---|---|---|---|
United States | Gastroenterology Associates of Sarasota | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Adenocyte, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Does LINFU™ yield an adequate number of cells that can be used to help diagnose pancreatic precancers and cancers? | The cells obtained from all 10 patients undergoing LINFU™ will be analyzed microscopically and counted by a pathologist for adequacy of pancreatic cellular yield. For a LINFU test to be considered adequate, 100 well-preserved ductal cells per patient must be counted under the microscope. Cellularity of >50 or <100 cells per patient would be interpreted as "limited but adequate" and cellularity <50 cells is unsatisfactory for adequacy. | 4 months |
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