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

NCT06276803 | Not Yet Recruiting

• 1 other identifier: Adenocyte 104
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Pancreatic Dysplasia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5 years

Secondary Outcomes (1)

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

  5 years

Other Outcomes (1)

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

  5 years

Study Arms (1)

Patients who have no risk factors for PDAC

In this study, LINFU® will be evaluated to help identify pancreatic intraepithelial neoplasia-2 (PanIn-2), pancreatic intraepithelial neoplasia-3 (PanIn-3), and early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) in patients with no risk factors and who do not display signs or symptoms of pancreatic disease.

Diagnostic Test: LINFU®

Interventions

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.

Patients who have no risk factors for PDAC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

You may not qualify if:

• Patient under the age of 18 and over the age 90
• Contraindications to LINFU®/EUS/ERCP as determined by study investigators:
• 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)
• 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
• Patients who consume alcohol (greater than 3 drinks/day \>1 year or \>15g/day for \>1 year will be excluded
• Patient with any history of adult-onset diabetes will be excluded
• Patients who are obese (body mass index \[BMI\] of 30 or more) will be excluded
• Patients who have consumed tobacco in the past for greater than 1 year or current smokers will be excluded.
• 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)
• Patients with baseline lipase levels that are abnormal
• Pregnant females will be excluded
• Patient that is unable to provide informed consent
• Patient with known allergy to the microbubble contrast agent or secretin

Sponsors & Collaborators

• Adenocyte, LLC: lead

Biospecimen

Retention: SAMPLES WITH DNA

Slides and cell blocks made from pancreatic fluid collected

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Gregory Haber, MD FRCP

  Manhattan Endoscopy Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Lazarus

CONTACT

9142632030; slazarus@adenocyte.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2034
• Study Completion (Estimated): December 15, 2034
• Last Updated: July 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share