Hepatic Xenetix-CT Perfusion

Phase 4

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Xenetix-CT perfusion imaging

• Registration Number: NCT01639703
• Lead Sponsor: Guerbet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-13
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-12-16
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-11
• Last Update Submitted: 2017-07-11
• Results First Posted: 2017-07-13
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT perfusion	Xenetix-CT perfusion imaging	arm with CT perfusion

Primary Outcome Measures

Name	Time	Method
Permeability Surface (PS) According to Degree of Lesions Differentiation	Within a week from CT perfusion to surgery	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	Within a week from CT perfusion to surgery	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 (BV) According to Degree of Lesions Differentiation	Within a week from CT perfusion to surgery	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

Name	Time	Method
Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation	Within a week from CT perfusion to surgery	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)	Within a week from CT perfusion to surgery	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 (Glutamine Synthetase)	Within a week from CT perfusion to surgery	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.
Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation	Within a week from CT perfusion to surgery	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	Within a week from CT perfusion to surgery	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
Blood Volume According to Immunohistochemistry Parameter (CD31)	Within a week from CT perfusion to surgery	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.
Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation	Within a week from CT perfusion to surgery	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 According to Immunohistochemistry Parameter (CD31)	Within a week from CT perfusion to surgery	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)	Within a week from CT perfusion to surgery	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)	Within a week from CT perfusion to surgery	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.

Trial Locations

Locations (5)

Zurich University Hospital; 🇨🇭 Zurich, Switzerland

SNUH; 🇰🇷 Seoul, Korea, Republic of

AKH; 🇦🇹 Vienna, Austria

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

SMC; 🇰🇷 Seoul, Korea, Republic of