Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers

Pilot Trial Comparing Circulating Tumor DNA (ctDNA) From Immediate Draining Vein vs. Standard Peripheral Vein Sample in Patients Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers

This is a prospective pilot protocol investigating whether ctDNA detection be improved by sampling the cancer draining vein versus the standard practice of sampling from a peripheral vein in patients who are undergoing biopsies for hepatobiliary and pancreatic cancers.

This is a, prospective single center pilot study to investigate whether ctDNA detection can be improved by sampling the cancer draining vein vs. a peripheral vein (current practice). As a secondary endpoint, both ctDNA results will be compared with percutaneous biopsy (standard of care).

Inclusion Criteria:

• 18 years of age or older
• Have or are undergoing work-up for hepatobiliary and/or pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)
• Scheduled for an image-guided percutaneous or trans-jugular biopsy of a lesion
• Must be able to provide a written informed consent

Exclusion Criteria:

• Patients unable to hold reasonably still on a procedure table or hold their breath during imaging or needle passes
• Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
• Patients with uncorrectable coagulopathy
• Platelet count < 30,000/ul
• International Normalized (INR) > 1.5
• Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage
• No clear reachable target for percutaneous or trans-jugular biopsy
• Patient who cannot have a peripheral blood draw for ctDNA