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Completed

NCT Number: NCT01639703

Hepatic Xenetix-CT Perfusion

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AKH, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xenetix-CT perfusion imaging

Drug

Injection of 50 ml of Xenetix

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 13, 2012
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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