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NOT YET RECRUITING

NCT06276803

The LINFU® U.S. Registry for the in the General Population Without Risk Factors

Sponsor: Adenocyte, LLC

View on ClinicalTrials.gov

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).

Official title: The LINFU® U.S. Registry for the Detection of Low and High-Grade Atypia and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC) in the General Population Without Risk Factors

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2024-09-15

Completion Date

2034-12-15

Last Updated

2024-07-31

Healthy Volunteers

Yes

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.

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, who in the opinion of the Investigator, do not exhibit any symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc. 3. Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC 4. Patients, who in the opinion of the Investigator, should not be ordinarily screened for PDAC because they do not have risk factors including chronic pancreatitis, family history of PDAC, or genetic cancer syndromes which increase the risk of developing PDAC 5. 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. Contraindications to LINFU®/EUS/ERCP as determined by study investigators: 1. Patient with uncorrectable coagulopathy 2. Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist 3. Unstable medically (cardiopulmonary, neurologic, or cardiovascular status) 3. Patients, who in the opinion of the Investigator, are at risk of PDAC because they exhibit any of the following: clinical symptoms of PDAC, imaging abnormalities suggestive of PDAC, genetic syndromes which increase the risk of PDAC, a first degree relative with a history of pancreatic cancer, excessive exposure to dry-cleaning and metalworking chemicals 4. Patients who consume alcohol (greater than 3 drinks/day \>1 year or \>15g/day for \>1 year will be excluded 5. Patient with any history of adult-onset diabetes will be excluded 6. Patients who are obese (body mass index \[BMI\] of 30 or more) will be excluded 7. Patients who have consumed tobacco in the past for greater than 1 year or current smokers will be excluded. 8. Patients with a history of any pancreatic disease, including chronic pancreatitis, or any pancreatic imaging abnormality including intraductal papillary mucinous neoplasm of the pancreas (IPMN) 9. Patients with baseline lipase levels that are abnormal 10. Pregnant females will be excluded 11. Patient that is unable to provide informed consent 12. Patient with known allergy to the microbubble contrast agent or secretin