Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer

NCT04793633 | Enrolling By Invitation

• 1 other identifier: Adenocyte 110
• Study Type: observational
• Target: 500
• 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 Ductal Adenocarcinoma

Keywords

Pancreatic Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• The number of pancreatic ductal adenocarcinomas and their noninvasive precursor

  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.

  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) or have signs or symptoms of disease and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer

Combination Product: LINFU™ Technique

Interventions

LINFU™ Technique COMBINATION_PRODUCT

Non-focused ultrasound excitation of the pancreas with IV Lumason and IV secretin injected during the ultrasound procedure.

Patients at increased risk for developing 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

Patients with risk factors for pancreatic cancer or those with signs and symptoms of 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 and 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 or signs or symptoms of PDAC
• High risk asymptomatic patients being screened for PDAC
• Patients with clinical signs or symptoms of PDAC including abnormal imaging and who are scheduled for EUS- FNA, MRI/MRCP, ERCP, or CT will be enrolled
• 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 undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
• 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)

Sarasota Memorial HealthCare System

Sarasota, Florida, 34239, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Slides and cell blocks made from pancreatic fluid collected

Study Officials

• Kenneth B Meredith, MD

  Sarasota Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: January 31, 2024
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)