Hepatic Xenetix-CT Perfusion

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Xenetix-CT perfusion imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT perfusion<br>arm with CT perfusion | Drug: Xenetix-CT perfusion imaging<br>* Injection of 50 ml of Xenetix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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 | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 
| 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. | Within a week from CT perfusion to surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT perfusion, Hepatocellular Carcinoma, Xenetix, Contrast agent