Hepatic Xenetix-CT Perfusion

July 11, 2017 updated by: Guerbet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • AKH
  • Germany
      • Erlangen, Germany
        • Universitatsklinikum Erlangen
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • SNUH
      • Seoul, Korea, Republic of
        • SMC
  • Switzerland
      • Zurich, Switzerland
        • Zurich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Volume (BV) According to Degree of Lesions Differentiation
Time Frame: 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.
Within a week from CT perfusion to surgery
Blood Flow (BF) According to Degree of Lesions Differentiation
Time Frame: 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.
Within a week from CT perfusion to surgery
Permeability Surface (PS) According to Degree of Lesions Differentiation
Time Frame: 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.
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
Time Frame: 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.
Within a week from CT perfusion to surgery
Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation
Time Frame: 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.
Within a week from CT perfusion to surgery
Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation
Time Frame: 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
Within a week from CT perfusion to surgery
Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation
Time Frame: 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.
Within a week from CT perfusion to surgery
Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)
Time Frame: 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.
Within a week from CT perfusion to surgery
Blood Volume According to Immunohistochemistry Parameter (CD31)
Time Frame: 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.
Within a week from CT perfusion to surgery
Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)
Time Frame: 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.
Within a week from CT perfusion to surgery
Blood Flow According to Immunohistochemistry Parameter (CD31)
Time Frame: 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.
Within a week from CT perfusion to surgery
Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)
Time Frame: 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.
Within a week from CT perfusion to surgery
Permeability Surface According to Immunohistochemistry Parameter (CD31)
Time Frame: 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.
Within a week from CT perfusion to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Investigators

  • Principal Investigator: Hatem Alkadhi, Zurich University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 13, 2012

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISO-44-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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