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

University of California Irvine (UCI)

Status: Enrolling

Conditions: Hepatobiliary Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Ampullary Cancer; Pancreatic Carcinoma; Pancreatic Cancer

Treatments: Diagnostic Test: ctDNA Blood Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT05497531

UCI 21-124 (Other Identifier)

1491 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

ctDNA collection from draining and peripheral veins

Experimental group

Description:

Patient with suspected primary hepatobiliary or pancreatic cancer undergoing a diagnostic work-up with a percutaneous or trans-jugular biopsy (standard of care) and will undergo a sampling of the cancer draining vein during their biopsy procedure with a collection of an additional 10mL of blood.

Treatment:

Diagnostic Test: ctDNA Blood Collection