Back to resultsHepatic Xenetix-CT Perfusion
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Xenetix-CT perfusion imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring CT perfusion, Hepatocellular Carcinoma, Xenetix, Contrast agent
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.
Sites / Locations
- AKH
- Universitätsklinikum Erlangen
- SMC
- SNUH
- Zurich University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT perfusion
Arm Description
arm with CT perfusion
Outcomes
Primary Outcome Measures
Blood Volume (BV) According to Degree of Lesions Differentiation
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Blood Flow (BF) According to Degree of Lesions Differentiation
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Permeability Surface (PS) According to Degree of Lesions Differentiation
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Secondary Outcome Measures
Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
TLP = ALP + PVP
Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Blood Volume According to Immunohistochemistry Parameter (CD31)
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Blood Flow According to Immunohistochemistry Parameter (CD31)
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Permeability Surface According to Immunohistochemistry Parameter (CD31)
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01639703
Brief Title
Hepatic Xenetix-CT Perfusion
Official Title
Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
CT perfusion, Hepatocellular Carcinoma, Xenetix, Contrast agent
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT perfusion
Arm Type
Experimental
Arm Description
arm with CT perfusion
Intervention Type
Drug
Intervention Name(s)
Xenetix-CT perfusion imaging
Intervention Description
Injection of 50 ml of Xenetix
Primary Outcome Measure Information:
Title
Blood Volume (BV) According to Degree of Lesions Differentiation
Description
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Time Frame
Within a week from CT perfusion to surgery
Title
Blood Flow (BF) According to Degree of Lesions Differentiation
Description
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Time Frame
Within a week from CT perfusion to surgery
Title
Permeability Surface (PS) According to Degree of Lesions Differentiation
Description
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Time Frame
Within a week from CT perfusion to surgery
Secondary Outcome Measure Information:
Title
Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation
Description
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Time Frame
Within a week from CT perfusion to surgery
Title
Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation
Description
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Time Frame
Within a week from CT perfusion to surgery
Title
Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation
Description
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
TLP = ALP + PVP
Time Frame
Within a week from CT perfusion to surgery
Title
Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation
Description
The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
Time Frame
Within a week from CT perfusion to surgery
Title
Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)
Description
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Time Frame
Within a week from CT perfusion to surgery
Title
Blood Volume According to Immunohistochemistry Parameter (CD31)
Description
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Time Frame
Within a week from CT perfusion to surgery
Title
Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)
Description
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Time Frame
Within a week from CT perfusion to surgery
Title
Blood Flow According to Immunohistochemistry Parameter (CD31)
Description
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Time Frame
Within a week from CT perfusion to surgery
Title
Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)
Description
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Time Frame
Within a week from CT perfusion to surgery
Title
Permeability Surface According to Immunohistochemistry Parameter (CD31)
Description
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Time Frame
Within a week from CT perfusion to surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Alkadhi
Organizational Affiliation
Zurich University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKH
City
Vienna
Country
Austria
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
SMC
City
Seoul
Country
Korea, Republic of
Facility Name
SNUH
City
Seoul
Country
Korea, Republic of
Facility Name
Zurich University Hospital
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Hepatic Xenetix-CT Perfusion
We'll reach out to this number within 24 hrs