The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease

NCT06276738 | Not Yet Recruiting

• 1 other identifier: Adenocyte 102
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.

Conditions

Pancreatic Cancer; Jaundice; Abdominal Neoplasm

Outcome Measures

Primary Outcomes (1)

• The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods

  The total number of pancreatic ductal adenocarcinomas identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including endoscopic ultrasound ± fine needle aspiration (EUS± FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP),computed tomography (CT) or contrast-enhanced ultrasound (CEUS).

  5 years

Secondary Outcomes (2)

• The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined

  5 years

• Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention

  5 years

Other Outcomes (1)

• Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU®

  5 years

Study Arms (1)

Patients at increased risk for developing pancreatic cancer

Patients who exhibit symptoms suggestive of PDAC (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) or have evidence of imaging studies suggestive of PDAC will undergo LINFU® testing.

Diagnostic Test: LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas)

Interventions

LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas) DIAGNOSTIC_TEST

Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes. A contrast agent will be administered IV at five minute intervals. The patient will then receive a dose of secretin and the the patient's pancreatic juice will then be collected for a total of 15 minutes.

Patients at increased risk for developing pancreatic cancer

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

High risk patients with either clinical symptoms or imaging abnormalities or both, being evaluated for 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, require biopsy to rule out PDAC because they display at least one of the following or both: a) clinical 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. b) one or more imaging studies suggestive of PDAC
• All patients must undergo contemporaneous imaging, either within 90 days before the LINFU® procedure or within 30 days after the procedure, 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: 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
• Patients who are already known to have PDAC by cytologic or histologic evidence
• Patients with intraductal papillary mucinous neoplasm of the pancreas (IPMN) identified either before the study or during the study through imaging evaluation will be excluded
• 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; Jaundice; Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Gregory Haber

  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: June 30, 2024
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): May 1, 2034
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share