The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease
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.
- EligibilityCriteria: 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 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: High risk patients with either clinical symptoms or imaging abnormalities or both, being evaluated for PDAC. - SamplingMethod: Non-Probability Sample