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

NCT ID: NCT06276738

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2034-05-01

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.

Detailed Description

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.

In this study, LINFU® will be evaluated in 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. In addition, patients with PDAC identified only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and to determine whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Conditions

Pancreatic Cancer; Jaundice; Abdominal Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adenocyte, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Haber

Role: PRINCIPAL_INVESTIGATOR

Manhattan Endoscopy Center

Central Contacts

Stephanie Lazarus

Role: CONTACT

slazarus@adenocyte.com

9142632030

Other Identifiers

Adenocyte 102

Identifier Type: -

Identifier Source: org_study_id