Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

Rush University Medical Center7 enrolled

Overview

This project investigates the feasibility of assessing the relative blood volume of carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an interventional platform.

This project will enroll patients with non-diffuse liver disease who are candidates for chemo or radioembolization to treat or manage the disease during an image guided intervention. Subjects will undergo a CT perfusion study of the liver prior to the radioembolizaiton mapping procedure or prior to the chemoembolization treatment. During the radioembolization mapping or chemoembolization procedure, 2 DynaCT acquisitions on the interventional C-arm will be acquired (the second during an injection of an iodinated contrast material) and will be processed using Siemens' PBV software to generate blood volume maps. The diagnostic accuracy of the two approaches to assess the vascularity of the tumors will be assessed.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocellular Carcinoma Metastatic Carcinoma to the Liver

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HCC or metastatic liver disease * Candidate for radioembolization or chemoembolization Exclusion Criteria: * Pregnant * Iodine allergy

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Diagnostic accuracy of PBV maps

The accuracy of the DynaCT BV protocol as an indicator of healthy vs. liver tumor compared to the body CT perfusion study will evaluated using a receiver operating characteristic curve.

Time frame: 1 year

Secondary Outcomes

Relationship between blood volume values and patient treatment response

The relationship between the BV values obtained by both methods and treatment response (as measured by RECIST values) will be evaluated by a logistic regression model

Time frame: 1,4,7,13,19 months

PBV blood volume value accuracy

A Spearman's correlation coefficient will be used to test the rank-based correlation of the BV values in tumor from the DynaCT BV acquisition to the body CT perfusion values. Furthermore, a paired t-test will be used to test for differences in BV using the two approaches.

Time frame: 1 year

Data from ClinicalTrials.gov

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