Hepatic Xenetix-CT Perfusion

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639703
• Other study ID #: ISO-44-013
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2012
• Last updated: July 11, 2017
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: July 2017
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Austria	AKH	Vienna
Germany	Universitätsklinikum Erlangen	Erlangen
Korea, Republic of	SMC	Seoul
Korea, Republic of	SNUH	Seoul
Switzerland	Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

Austria,  Germany,  Korea, Republic of,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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