Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT perfusion | Experimental | arm with CT perfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenetix-CT perfusion imaging | Drug | Injection of 50 ml of Xenetix |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hatem Alkadhi | Zurich University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH | Vienna | Austria | ||||
| Universitätsklinikum Erlangen |
Not provided
A total of 96 patients were enrolled in 4 countries: Austria, Germany, South Korea and Switzerland.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CT Perfusion | Xenetix-CT perfusion imaging: Injection of 50 ml of Xenetix |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Included Patients | All patients included in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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". | Posted | Mean | Standard Deviation | mL/100 grams | Within a week from CT perfusion to surgery | lesions | lesions |
|
Adverse events were recorded during and immediately after the CT perfusion examination over a 30 min follow up period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Set | All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing | Guerbet | +33 (0) 1 45 91 50 00 | corinne.dubourdieu@guerbet-group.com |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Erlangen |
| Germany |
| SMC | Seoul | South Korea |
| SNUH | Seoul | South Korea |
| Zurich University Hospital | Zurich | Switzerland |
| years |
|
| Sex: Female, Male | For one patient, the gender was missing. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Severity of cirrhosis (Child-Pugh score) | 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.
For 7 patients, this score was missing. | Count of Participants | Participants |
|
| OG001 |
| Moderately/Poorly Differentiated Lesions |
Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification. |
|
|
| 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. | 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". | Posted | Mean | Standard Deviation | mL/100 grams/min | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
| 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. | 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". | Posted | Mean | Standard Deviation | mL/100 grams/min | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
| 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. | 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". | Posted | Mean | Standard Deviation | mL/min/100 mL | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
| 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. | 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". | Posted | Mean | Standard Deviation | mL/min/100 mL | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
| 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 | 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". | Posted | Mean | Standard Deviation | mL/min/100 mL | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
| 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. | 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". | Posted | Mean | Standard Deviation | percentage | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/100 grams | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
|
| 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. | A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions. | Posted | Mean | Standard Deviation | mL/100 grams | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/100 grams/min | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
|
| 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. | A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions. | Posted | Mean | Standard Deviation | mL/100 grams/min | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/100 grams/min | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
|
| 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. | A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions. | Posted | Mean | Standard Deviation | mL/100 grams/min | Within a week from CT perfusion to surgery | lesions | lesions |
|
|
|
|
| 0 |
| 84 |
| 4 |
| 84 |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
All written or oral papers and publications must have the joint agreement of the investigator and the sponsor.
Each investigator agrees not to publish/submit/present the results of the study main criterion involving only the patients he/she has included.
Any abstract project will be first submitted to Guerbet at least 10 working days before submission to the congress scientific committee.
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| lesions |
|
| lesions |
|
| lesions |
|
| lesions |
|
| lesions |
|
| lesions |
|