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

ConditionsPancreatic Cancer Pancreatic Ductal Adenocarcinoma Pancreatic Dysplasia

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-90

SponsorAdenocyte, LLC

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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, 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.

Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC

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

Disqualifiers

Patient under the age of 18 and over the age 90

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)

Trial population

Patients who do not exhibit any symptoms of PDAC, do not have an abnormal imaging study suggestive of PDAC and who do not have risk factors which increase the risk of developing PDAC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

LINFU®
Diagnostic test
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.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Patients who have no risk factors for PDAC1 intervention

Trial outcomes

Primary outcomes

The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU®

The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions (PanIn-2, PanIn-3) identified with LINFU® by analysis of pancreatic fluid will be recorded.

Time frame

5 years

The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term

Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention.

Time frame

5 years

Secondary outcomes

Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention

Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be monitored long- term (5 years) by standard imaging studies (EUS- FNA, MRI/MRCP, ERCP, CT and CEUS) to assess whether these tumors increase and to determine how many require medical or surgical intervention.

Time frame

5 years

Other outcomes

Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified with LINFU®

Patients will be followed by standard imaging studies (EUS- FNA, MRI/MRCP, ERCP, CT and CEUS) and yearly survival rates of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be recorded.

Time frame

5 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adenocyte, LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: