Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 11:27 PM
Study NCT ID:
NCT01639703
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2012-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hepatic Xenetix-CT Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'corinne.dubourdieu@guerbet-group.com', 'phone': '+33 (0) 1 45 91 50 00', 'title': 'Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing', 'organization': 'Guerbet'}, 'certainAgreement': {'otherDetails': 'All written or oral papers and publications must have the joint agreement of the investigator and the sponsor.\n\nEach investigator agrees not to publish/submit/present the results of the study main criterion involving only the patients he/she has included.\n\nAny abstract project will be first submitted to Guerbet at least 10 working days before submission to the congress scientific committee.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded during and immediately after the CT perfusion examination over a 30 min follow up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Safety Set', 'description': 'All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses.', 'otherNumAtRisk': 84, 'otherNumAffected': 4, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Volume (BV) According to Degree of Lesions Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Well Differentiated Lesions', 'description': 'Among the 90 lesions analyzed for CT perfusion parameters, 47 were well differentiated according to WHO classification.'}, {'id': 'OG001', 'title': 'Moderately/Poorly Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.930', 'spread': '6.663', 'groupId': 'OG000'}, {'value': '13.958', 'spread': '5.315', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/100 grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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".'}, {'type': 'PRIMARY', 'title': 'Blood Flow (BF) According to Degree of Lesions Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Well Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.'}, {'id': 'OG001', 'title': 'Moderately/Poorly Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.042', 'spread': '21.551', 'groupId': 'OG000'}, {'value': '72.051', 'spread': '31.792', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/100 grams/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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".'}, {'type': 'PRIMARY', 'title': 'Permeability Surface (PS) According to Degree of Lesions Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Well Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.'}, {'id': 'OG001', 'title': 'Moderately/Poorly Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.421', 'spread': '10.014', 'groupId': 'OG000'}, {'value': '27.750', 'spread': '9.425', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/100 grams/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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".'}, {'type': 'SECONDARY', 'title': 'Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Well Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification'}, {'id': 'OG001', 'title': 'Moderately/Poorly Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.234', 'spread': '16.989', 'groupId': 'OG000'}, {'value': '42.967', 'spread': '16.678', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/min/100 mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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".'}, {'type': 'SECONDARY', 'title': 'Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Well Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.'}, {'id': 'OG001', 'title': 'Moderately/Poorly Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.492', 'spread': '14.586', 'groupId': 'OG000'}, {'value': '13.708', 'spread': '13.207', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/min/100 mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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".'}, {'type': 'SECONDARY', 'title': 'Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Well Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.'}, {'id': 'OG001', 'title': 'Moderately/Poorly Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.725', 'spread': '15.620', 'groupId': 'OG000'}, {'value': '56.674', 'spread': '20.494', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.\n\nTLP = ALP + PVP', 'unitOfMeasure': 'mL/min/100 mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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".'}, {'type': 'SECONDARY', 'title': 'Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Well Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.'}, {'id': 'OG001', 'title': 'Moderately/Poorly Differentiated Lesions', 'description': 'Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.232', 'spread': '18.458', 'groupId': 'OG000'}, {'value': '80.834', 'spread': '14.503', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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".'}, {'type': 'SECONDARY', 'title': 'Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}, {'units': 'lesions', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine Synthetase 0%', 'description': 'Absence of glutamine synthetase labelling'}, {'id': 'OG001', 'title': 'Glutamine Synthetase 1-10%', 'description': 'Quantification of glutamine synthetase labelling from 1 to 10%'}, {'id': 'OG002', 'title': 'Glutamine Synthetase 10-50%', 'description': 'Quantification of glutamine synthetase labelling from 10 to 50%'}, {'id': 'OG003', 'title': 'Glutamine Synthetase >50%', 'description': 'Quantification of glutamine synthetase labelling greater than 50%'}], 'classes': [{'categories': [{'measurements': [{'value': '14.994', 'spread': '5.714', 'groupId': 'OG000'}, {'value': '12.964', 'spread': '5.268', 'groupId': 'OG002'}, {'value': '15.551', 'spread': '6.328', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2476', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.21', 'estimateComment': 'Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \\>50%) considering an increase of 5 units for Blood Volume', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': 'Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.\n\nGlutamine 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.', 'unitOfMeasure': 'mL/100 grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Blood Volume According to Immunohistochemistry Parameter (CD31)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'lesions', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD31 0%', 'description': 'Absence of CD31 labelling'}, {'id': 'OG001', 'title': 'CD31 1-10%', 'description': 'Quantification of CD31 labelling from 1 to 10%'}, {'id': 'OG002', 'title': 'CD31 10-50%', 'description': 'Quantification of CD31 labelling from 10 to 50%'}, {'id': 'OG003', 'title': 'CD31 >50%', 'description': 'Quantification of CD31 labelling greater than 50%'}], 'classes': [{'categories': [{'measurements': [{'value': '14.708', 'spread': '7.657', 'groupId': 'OG001'}, {'value': '15.589', 'spread': '4.561', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5354', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.66', 'estimateComment': 'Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \\>50%) considering an increase of 5 units for Blood Volume', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/100 grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.'}, {'type': 'SECONDARY', 'title': 'Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}, {'units': 'lesions', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine Synthetase 0%', 'description': 'Absence of glutamine synthetase labelling'}, {'id': 'OG001', 'title': 'Glutamine Synthetase 1-10%', 'description': 'Quantification of glutamine synthetase labelling from 1 to 10%'}, {'id': 'OG002', 'title': 'Glutamine Synthetase 10-50%', 'description': 'Quantification of glutamine synthetase labelling from 10 to 50%'}, {'id': 'OG003', 'title': 'Glutamine Synthetase >50%', 'description': 'Quantification of glutamine synthetase labelling greater than 50%'}], 'classes': [{'categories': [{'measurements': [{'value': '79.178', 'spread': '32.656', 'groupId': 'OG000'}, {'value': '61.804', 'spread': '22.087', 'groupId': 'OG002'}, {'value': '74.261', 'spread': '27.619', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3487', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.13', 'estimateComment': 'Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \\>50%) considering an increase of 10 units for Blood Flow', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': 'Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.\n\nGlutamine 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.', 'unitOfMeasure': 'mL/100 grams/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Blood Flow According to Immunohistochemistry Parameter (CD31)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'lesions', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD31 0%', 'description': 'Absence of glutamine synthetase labelling'}, {'id': 'OG001', 'title': 'CD31 1-10%', 'description': 'Quantification of CD31 labelling from 1 to 10%'}, {'id': 'OG002', 'title': 'CD31 10-50%', 'description': 'Quantification of CD31 labelling from 10 to 50%'}, {'id': 'OG003', 'title': 'CD31 >50%', 'description': 'Quantification of CD31 labelling greater than 50%'}], 'classes': [{'categories': [{'measurements': [{'value': '70.057', 'spread': '25.317', 'groupId': 'OG001'}, {'value': '75.206', 'spread': '28.519', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4195', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.29', 'estimateComment': 'Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \\>50%) considering an increase of 10 units for Blood Flow', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/100 grams/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.'}, {'type': 'SECONDARY', 'title': 'Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}, {'units': 'lesions', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glutamine Synthetase 0%', 'description': 'Absence of glutamine synthetase labelling'}, {'id': 'OG001', 'title': 'Glutamine Synthetase 1-10%', 'description': 'Quantification of glutamine synthetase labelling from 1 to 10%'}, {'id': 'OG002', 'title': 'Glutamine Synthetase 10-50%', 'description': 'Quantification of glutamine synthetase labelling from 10 to 50%'}, {'id': 'OG003', 'title': 'Glutamine Synthetase >50%', 'description': 'Quantification of glutamine synthetase labelling greater than 50%'}], 'classes': [{'categories': [{'measurements': [{'value': '28.896', 'spread': '7.207', 'groupId': 'OG000'}, {'value': '24.840', 'spread': '6.769', 'groupId': 'OG002'}, {'value': '27.139', 'spread': '10.714', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7127', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.54', 'estimateComment': 'Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \\>50%) considering an increase of 10 units for Permeability Surface', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': 'Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.\n\nGlutamine 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.', 'unitOfMeasure': 'mL/100 grams/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Permeability Surface According to Immunohistochemistry Parameter (CD31)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'lesions', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CD31 0%', 'description': 'Absence of CD31 labelling'}, {'id': 'OG001', 'title': 'CD31 1-10%', 'description': 'Quantification of CD31 labelling from 1 to 10%'}, {'id': 'OG002', 'title': 'CD31 10-50%', 'description': 'Quantification of CD31 labelling from 10 to 50%'}, {'id': 'OG003', 'title': 'CD31 >50%', 'description': 'Quantification of CD31 labelling greater than 50%'}], 'classes': [{'categories': [{'measurements': [{'value': '25.434', 'spread': '9.721', 'groupId': 'OG001'}, {'value': '28.587', 'spread': '9.832', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1753', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.86', 'ciUpperLimit': '2.31', 'estimateComment': 'Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \\>50%) considering an increase of 10 units for Permeability Surface', 'groupDescription': '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.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.', 'unitOfMeasure': 'mL/100 grams/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT Perfusion', 'description': 'Xenetix-CT perfusion imaging: Injection of 50 ml of Xenetix'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'A total of 96 patients were enrolled in 4 countries: Austria, Germany, South Korea and Switzerland.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Included Patients', 'description': 'All patients included in the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.2', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For one patient, the gender was missing.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Korea, Republic of', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Severity of cirrhosis (Child-Pugh score)', 'classes': [{'title': 'Class A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': 'Class B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Class C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.\n\n* Class A: well compensated disease\n* Class B: significant functional compromised\n* Class C: decompensated disease\n\nFor 7 patients, this score was missing.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2012-07-06', 'resultsFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2012-07-12', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-11', 'studyFirstPostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Volume (BV) According to Degree of Lesions Differentiation', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}, {'measure': 'Blood Flow (BF) According to Degree of Lesions Differentiation', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}, {'measure': 'Permeability Surface (PS) According to Degree of Lesions Differentiation', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}, {'measure': 'Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}, {'measure': 'Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.\n\nTLP = ALP + PVP'}, {'measure': 'Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}, {'measure': 'Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': 'Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.\n\nGlutamine 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.'}, {'measure': 'Blood Volume According to Immunohistochemistry Parameter (CD31)', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}, {'measure': 'Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': 'Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.\n\nGlutamine 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.'}, {'measure': 'Blood Flow According to Immunohistochemistry Parameter (CD31)', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}, {'measure': 'Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': 'Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.\n\nGlutamine 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.'}, {'measure': 'Permeability Surface According to Immunohistochemistry Parameter (CD31)', 'timeFrame': 'Within a week from CT perfusion to surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CT perfusion', 'Hepatocellular Carcinoma', 'Xenetix', 'Contrast agent'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT01639703', 'briefTitle': 'Hepatic Xenetix-CT Perfusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guerbet'}, 'officialTitle': 'Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'ISO-44-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT perfusion', 'description': 'arm with CT perfusion', 'interventionNames': ['Drug: Xenetix-CT perfusion imaging']}], 'interventions': [{'name': 'Xenetix-CT perfusion imaging', 'type': 'DRUG', 'description': 'Injection of 50 ml of Xenetix', 'armGroupLabels': ['CT perfusion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMC', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'SNUH', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Zurich University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Hatem Alkadhi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zurich University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guerbet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}