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

Not Applicable
Recruiting
Conditions
Cholangiocarcinoma
Ampullary Cancer
Hepatobiliary Cancer
Pancreatic Cancer
Hepatocellular Carcinoma
Pancreatic Carcinoma
Registration Number
NCT05497531
Lead Sponsor
University of California, Irvine
Brief Summary

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.

Detailed 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).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
15
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequencyUp to 1 year

Ratio of mean allele frequency (MAF)% of hepatic or portal draining vein, and MAF% of peripheral blood will be utilized to compare the samples

Secondary Outcome Measures
NameTimeMethod
Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS)Up to 1 year

ctDNA results will be compared with percutaneous biopsy (standard of care)

Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasmaUp to 1 year

ctDNA results will be compared with percutaneous biopsy (standard of care)

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

🇺🇸

Orange, California, United States

Chao Family Comprehensive Cancer Center, University of California, Irvine
🇺🇸Orange, California, United States
Nadine Abi-Jaoudeh, MD
Contact
877-827-8839
ucstudy@uci.edu

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