Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02288910

Enrollment

Registered

2014-11-11

Start date

2014-11-30

Completion date

2020-07-31

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Metastatic Carcinoma to the Liver

Keywords

Liver Perfusion, DynaCT Perfusion, Radioembolization, Chemoembolization

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnant * Iodine allergy

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of PBV maps	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

Measure	Time frame	Description
Relationship between blood volume values and patient treatment response	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
PBV blood volume value accuracy	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.

Countries

United States

Outcome results