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

Adenocyte

Status: Not yet enrolling

Conditions: Abdominal Neoplasm; Jaundice; Pancreatic Cancer

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06276738

Adenocyte 102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Patients at increased risk for developing pancreatic cancer

Description:

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.

Treatment:

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