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

Launched by ADENOCYTE, LLC · Feb 18, 2024

Keywords

ClinConnect Summary

The LINFU® U.S. Registry is a clinical trial designed to study a specific treatment called LINFU® for patients who show signs or symptoms of pancreatic cancer, such as jaundice (yellowing of the skin and eyes), abdominal pain, weight loss, nausea, and vomiting. This study is looking for adults aged 18 to 90 who may need a biopsy to determine if they have pancreatic cancer based on their symptoms or imaging tests like CT scans or MRIs. It’s important for participants to have certain imaging tests done either shortly before or after the LINFU® procedure to help doctors gather necessary information.

To join the study, participants must be in generally good health and not have any serious medical conditions that would prevent them from safely undergoing the treatment. Pregnant women and those already diagnosed with pancreatic cancer are not eligible. The trial is currently not recruiting participants, but once it begins, those who qualify can expect to take part in tests and procedures related to their condition, all while being monitored by healthcare professionals. This research aims to improve understanding and treatment options for pancreatic cancer, potentially benefiting future patients.

Gender

ALL

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