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Completed

NCT Number: NCT02288910

Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Metastatic Carcinoma to the Liver Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HCC or metastatic liver disease
  • Candidate for radioembolization or chemoembolization

Exclusion criteria

  • Pregnant
  • Iodine allergy

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of PBV maps

    Time frame: 1 year

    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.

Secondary outcomes

  1. Relationship between blood volume values and patient treatment response

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

    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

  2. PBV blood volume value accuracy

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Nov 11, 2014
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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