The LINFU® U.S. Registry for the in the General Population Without Risk Factors
NCT06276803 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2024-07-31
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).
Conditions
- Pancreatic Cancer
- Pancreatic Ductal Adenocarcinoma
- Pancreatic Dysplasia
Interventions
- DIAGNOSTIC_TEST
-
LINFU®
Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes using a GE LOGIQ10 or other FDA approved, FDA cleared or FDA exempt ultrasound insonation. A contrast agent will be administered IV during the ultrasound insonation and the patient will also receive a dose of secretin. The pancreatic juice will then be collected for a total of 15 minutes.
Sponsors & Collaborators
-
Adenocyte, LLC
lead INDUSTRY
Principal Investigators
-
Gregory Haber, MD FRCP · Manhattan Endoscopy Center
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-15
- Primary Completion
- 2034-09-15
- Completion
- 2034-12-15
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