Clinical trial NCT06276803: The LINFU® U.S. Registry for the in the General Population Without Risk Factors
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Pancreatic Dysplasia
Lead sponsor: Adenocyte, LLC
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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).

Detailed description: Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) to increase the sensitivity of pancreatic juice cytology. LINFU® consists of analysis of pancreatic fluid collected with the help of low intensity non-focused ultrasound excitation of the pancreas. A contrast agent will be used to create bubbles and possibly increase the number of pancreatic cell we collect for the study. Secretin is also used to increase the number of pancreatic cell excretion to maximize the number of cells collected. A neural network-based computer-assisted system may be used to enhance the analysis of specimens.

In this registry, LINFU® will be studied in patients with no risk factors and who exhibit no signs or symptoms of disease. In this registry, a standardized Case Report Form will be completed for every subject enrolled. Information obtained at baseline will include patient history, clinical and demographic information. The results of all diagnostic tests, surgeries, and biopsies performed after the LINFU® technique for a period of 5 years will be recorded and maintained as clinical registry data. This includes testing and procedures received since enrollment including endoscopic ultrasound-fine-needle aspiration (EUS- FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP), computed tomography (CT), contrast-enhanced ultrasound (CEUS), treatments performed, pathology results, and pancreatic disease history since enrollment.

The registry case report form is the primary data collection instrument for the registry. All data requested on the form must be recorded and these forms will be monitored carefully by the sponsor to ensure they are completely filled out properly.

Eligibility criteria: 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

Primary outcomes:
measure: The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU®
timeFrame: 5 years
measure: The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term
timeFrame: 5 years
Secondary outcomes:
measure: Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention
timeFrame: 5 years
Other outcomes:
measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified with LINFU®
timeFrame: 5 years
Locations:
Study officials:
affiliation: Manhattan Endoscopy Center
name: Gregory Haber, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: