The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma

NCT06157671 | Enrolling By Invitation

• 1 other identifier: Adenocyte 101
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis. Patients enrolled are being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes).

Conditions

Pancreatic Adenocarcinoma; Pancreatic Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be compared to standard screening methods

  The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including EUS- FNA, MRI/MRCP, ERCP, CT and CEUS.

  5 years

Secondary Outcomes (2)

• The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period.

  5 years

• Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only 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 only with LINFU®

  5 years

Study Arms (1)

Patients at increased risk for developing pancreatic cancer

Patients being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes) and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High risk asymptomatic patients being screened for pancreatic cancer who are scheduled for EUS± FNA, MRI/MRCP, ERCP, CT or CEUS will be enrolled.

You may qualify if:

• Both males and females will be enrolled and must be at least 18 years of age under age of 90
• Patients who, in the opinion of the Investigator, are at elevated risk of developing a pancreatic malignancy because they have known risk factors for PDAC.
• High risk asymptomatic patients being screened for PDAC.
• All patients must undergo contemporaneous imaging (within 90 days of LINFU®) with one or more of the following: EUS± FNA, MRI/MRCP, ERCP, CT or CEUS.
• 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 including: 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 with clinical signs or symptoms of PDAC
• Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
• Patients with documented intraductal papillary mucinous neoplasm of the pancreas (IPMN)
• 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

Study Sites (1)

Manhattan Endoscopy Center

New York, New York, 10017, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Slides and cell blocks made from pancreatic fluid collected

Study Officials

• Gregory Haber, MD FRCP

  Manhattan Endoscopy Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 6, 2023
• Study Start: January 31, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)