Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Xenetix-CT perfusion imaging

Hatem Alkadhi

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.

Hepatic Xenetix-CT Perfusion

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

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.

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

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.

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.

Guerbet

All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses.

Safety Set

All Included Patients

Age, Continuous

Sex: Female, Male

Austria

Korea, Republic of

Switzerland

Germany

Region of Enrollment

Class A

Class B

Class C

Child-Pugh classification of severity of liver disease is evaluated according to the degree of ascites, the plasma concentrations of bilirubin and albumin, the prothrombin time, and the degree of encephalopathy.

* Class A: well compensated disease
* Class B: significant functional compromised
* Class C: decompensated disease

For 7 patients, this score was missing.

Severity of cirrhosis (Child-Pugh score)

Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing

Among the 90 lesions analyzed for CT perfusion parameters, 47 were well differentiated according to WHO classification.

Well Differentiated Lesions

Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.

Moderately/Poorly Differentiated Lesions

A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as "well differentiated", 42 had lesions assessed as "moderately/poorly differentiated" and 3 had lesions assessed as "well differentiated" and "moderately/poorly differentiated".

Blood Volume (BV) According to Degree of Lesions Differentiation

Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.

Blood Flow (BF) According to Degree of Lesions Differentiation

Permeability Surface (PS) According to Degree of Lesions Differentiation

Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification

Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation

Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation

Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation

Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation

Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.

Absence of glutamine synthetase labelling

Glutamine Synthetase 0%

Quantification of glutamine synthetase labelling from 1 to 10%

Glutamine Synthetase 1-10%

Quantification of glutamine synthetase labelling from 10 to 50%

Glutamine Synthetase 10-50%

Quantification of glutamine synthetase labelling greater than 50%

Glutamine Synthetase >50%

A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group \>50%; 2 patients presented at least 1 lesion in group \>50% and 1 missing data; 2 patients presented missing data.

Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)

CD31 0%

Quantification of CD31 labelling from 1 to 10%

CD31 1-10%

Quantification of CD31 labelling from 10 to 50%

CD31 10-50%

Quantification of CD31 labelling greater than 50%

CD31 >50%

A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.

Blood Volume According to Immunohistochemistry Parameter (CD31)

Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)

Blood Flow According to Immunohistochemistry Parameter (CD31)

Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)

Permeability Surface According to Immunohistochemistry Parameter (CD31)

Xenetix-CT perfusion imaging: Injection of 50 ml of Xenetix

Spots Global Cancer Trial Database for Hepatic Xenetix-CT Perfusion

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial