Clinical trial NCT01639703: Hepatic Xenetix-CT Perfusion
Official title: Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: CT perfusion
Hepatocellular Carcinoma
Xenetix
Contrast agent
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed for HCC and planned for surgery (lobectomy or transplantation) within a timeframe of 30 days between first imaging procedure used for the study and surgery.

Exclusion Criteria:

* Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one year before inclusion.

Primary outcomes:
measure: Blood Volume (BV) According to Degree of Lesions Differentiation
timeFrame: Within a week from CT perfusion to surgery
measure: Blood Flow (BF) According to Degree of Lesions Differentiation
timeFrame: Within a week from CT perfusion to surgery
measure: Permeability Surface (PS) According to Degree of Lesions Differentiation
timeFrame: Within a week from CT perfusion to surgery
Secondary outcomes:
measure: Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation
timeFrame: Within a week from CT perfusion to surgery
measure: Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation
timeFrame: Within a week from CT perfusion to surgery
measure: Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation
timeFrame: Within a week from CT perfusion to surgery
measure: Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation
timeFrame: Within a week from CT perfusion to surgery
measure: Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)
timeFrame: Within a week from CT perfusion to surgery
measure: Blood Volume According to Immunohistochemistry Parameter (CD31)
timeFrame: Within a week from CT perfusion to surgery
measure: Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)
timeFrame: Within a week from CT perfusion to surgery
measure: Blood Flow According to Immunohistochemistry Parameter (CD31)
timeFrame: Within a week from CT perfusion to surgery
measure: Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)
timeFrame: Within a week from CT perfusion to surgery
measure: Permeability Surface According to Immunohistochemistry Parameter (CD31)
timeFrame: Within a week from CT perfusion to surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Seoul
country: Korea, Republic of
facility: SMC
city: Seoul
country: Korea, Republic of
facility: SNUH
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
affiliation: Zurich University Hospital
name: Hatem Alkadhi
role: PRINCIPAL_INVESTIGATOR
References: