Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT00522951
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2007-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Sponsor:
Organization:
Raw JSON
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The interval of two bolus injections is 13-15 min'}, {'id': 'OG002', 'title': 'Gadoteridol (ProHance) 0.2mmol/kg bw', 'description': 'Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min'}], 'classes': [{'title': 'averaged blinded reader', 'categories': [{'measurements': [{'value': '6.28', 'spread': '8.31', 'groupId': 'OG000'}, {'value': '6.92', 'spread': '8.69', 'groupId': 'OG001'}, {'value': '6.87', 'spread': '8.65', 'groupId': 'OG002'}]}]}, {'title': 'investigator', 'categories': [{'measurements': [{'value': '6.36', 'spread': '8.26', 'groupId': 'OG000'}, {'value': '6.87', 'spread': '8.49', 'groupId': 'OG001'}, {'value': '6.66', 'spread': '8.41', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.29', 'estimateComment': 'Averaged blinded reader (primary analysis)', 'groupDescription': 'H01: μG1 - μPr ≤ -1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'non-inferiority margin = -1'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.36', 'estimateComment': 'Averaged blinded reader (primary analysis)', 'groupDescription': 'H02: μG2 - μPr ≤ -1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'non-inferiority margin = -1'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '-0.1', 'estimateComment': 'Investigator (secondary analysis)', 'groupDescription': 'H01: μG1 - μPr ≤ -1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'non-inferiority margin = -1'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.41', 'estimateComment': 'Investigator (secondary analysis)', 'groupDescription': 'H02: μG2 - μPr ≤ -1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'non-inferiority margin = -1'}], 'paramType': 'MEAN', 'timeFrame': 'one day', 'description': 'Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg bw', 'description': 'Participants received first injection (intravenous \\[i.v.\\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw'}, {'id': 'OG001', 'title': 'Gadobutrol 0.2 mmol/kg bw', 'description': 'Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min'}, {'id': 'OG002', 'title': 'Gadoteridol (ProHance) 0.2mmol/kg bw', 'description': 'Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min'}], 'classes': [{'categories': [{'measurements': [{'value': '3.44', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '3.51', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one day', 'description': 'Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg bw', 'description': 'Participants received first injection (intravenous \\[i.v.\\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw'}, {'id': 'OG001', 'title': 'Gadobutrol 0.2 mmol/kg bw', 'description': 'Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min'}, {'id': 'OG002', 'title': 'Gadoteridol (ProHance) 0.2mmol/kg bw', 'description': 'Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min'}], 'classes': [{'categories': [{'measurements': [{'value': '3.16', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '3.31', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one day', 'description': 'Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Score of Visibility Assessment - Border Delineation by Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg bw', 'description': 'Participants received first injection (intravenous \\[i.v.\\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw'}, {'id': 'OG001', 'title': 'Gadobutrol 0.2 mmol/kg bw', 'description': 'Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. 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The interval of two bolus injections is 13-15 min'}, {'id': 'OG002', 'title': 'Gadoteridol (ProHance) 0.2mmol/kg bw', 'description': 'Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min'}], 'classes': [{'categories': [{'measurements': [{'value': '3.10', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '3.22', 'spread': '0.68', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one day', 'description': 'Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw', 'description': 'Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)'}], 'classes': [{'title': 'Gado-not confident, Pro-not confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not confident, Pro-confident', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not confident, Pro-not assessable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-confident, Pro-not confident', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gado-confident, Pro-confident', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}]}]}, {'title': 'Gado-confident, Pro-not assessable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not assessable, Pro-not confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not assessable, Pro-confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not assessable, Pro-not assessable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one day', 'description': 'Treatment planning confidence evaluated separately for each image set (gadobutrol \\[Gado-\\] 0.1 mmol/kg bw and gadoteridol \\[Pro-\\] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for 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{'title': 'Gado-not confident, Pro-not assessable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-confident, Pro-not confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-confident, Pro-confident', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}]}]}, {'title': 'Gado-confident, Pro-not assessable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not assessable, Pro-not confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not assessable, Pro-confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gado-not assessable, Pro-not assessable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one day', 'description': 'Treatment planning confidence evaluated separately for each image set 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[{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ProHance was better: newly treatable lesions', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ProHance was better: extended radiation area', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ProHance was better: clarified radiation area', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ProHance was better: other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one day', 'description': 'Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as "confident in treatment planning" with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure'}, {'type': 'SECONDARY', 'title': 'Lesion Size Evaluated by Independent Radiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg bw', 'description': 'Participants received first injection (intravenous \\[i.v.\\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw'}, {'id': 'OG001', 'title': 'Gadobutrol 0.2 mmol/kg bw', 'description': 'Participants received second injection (i.v.) of gadobutrol 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The interval of two bolus injections is 13-15 min'}, {'id': 'OG002', 'title': 'Gadoteridol (ProHance) 0.2mmol/kg bw', 'description': 'Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. 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The interval of two bolus injections is 13-15 min'}, {'id': 'OG002', 'title': 'Gadoteridol (ProHance) 0.2mmol/kg bw', 'description': 'Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min'}], 'classes': [{'categories': [{'measurements': [{'value': '0.963', 'groupId': 'OG000'}, {'value': '0.955', 'groupId': 'OG001'}, {'value': '0.949', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one day', 'description': 'ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.', 'unitOfMeasure': 'ICC', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gadobutrol Then Gadoteridol', 'description': 'Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2'}, {'id': 'FG001', 'title': 'Gadoteridol Then Gadobutrol', 'description': 'Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'body motion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Subjects Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'residual contrast medium', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 175 participants were enrolled into the study. 10 were withdrawn from the study before entering Study Period 1. Safety Analysis Set included 164 participants; gadobutrol=161, ProHance=162. Per Protocol Set (PPS) included 151 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'includes all participants received treatment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '160.9', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primary focus', 'classes': [{'title': 'Lung cancer', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}, {'title': 'Breast cancer', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-28', 'studyFirstSubmitDate': '2007-08-29', 'resultsFirstSubmitDate': '2011-07-05', 'studyFirstSubmitQcDate': '2007-08-29', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-05', 'studyFirstPostDateStruct': {'date': '2007-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Lesions Detected by Blinded Readers (BR) and Investigator', 'timeFrame': 'one day', 'description': 'Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator'}], 'secondaryOutcomes': [{'measure': 'Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader', 'timeFrame': 'one day', 'description': 'Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)'}, {'measure': 'Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator', 'timeFrame': 'one day', 'description': 'Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)'}, {'measure': 'Score of Visibility Assessment - Border Delineation by Blinded Reader', 'timeFrame': 'one day', 'description': 'Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)'}, {'measure': 'Score of Visibility Assessment - Border Delineation by Investigator', 'timeFrame': 'one day', 'description': 'Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)'}, {'measure': 'Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)', 'timeFrame': 'one day', 'description': 'Treatment planning confidence evaluated separately for each image set (gadobutrol \\[Gado-\\] 0.1 mmol/kg bw and gadoteridol \\[Pro-\\] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)'}, {'measure': 'Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator', 'timeFrame': 'one day', 'description': 'Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)'}, {'measure': 'Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE', 'timeFrame': 'one day', 'description': 'Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)'}, {'measure': 'Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator', 'timeFrame': 'one day', 'description': 'Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)'}, {'measure': 'Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE', 'timeFrame': 'one day', 'description': 'Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE'}, {'measure': 'Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator', 'timeFrame': 'one day', 'description': 'Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator'}, {'measure': 'Number of Participants With Reasons for Performance in SRS Planning by TPE', 'timeFrame': 'one day', 'description': 'Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)'}, {'measure': 'Number of Participants With Reasons for Performance in SRS Planning by Investigator', 'timeFrame': 'one day', 'description': 'Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)'}, {'measure': 'Lesion Size Evaluated by Independent Radiologist', 'timeFrame': 'one day', 'description': 'Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)'}, {'measure': 'Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist', 'timeFrame': 'one day', 'description': 'CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)'}, {'measure': 'Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions', 'timeFrame': 'one day', 'description': 'ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRI', 'Brain Metastasis', 'Gadolinium', 'Imaging', 'Diagnostic Agent'], 'conditions': ['Brain Metastases']}, 'referencesModule': {'references': [{'pmid': '21467949', 'type': 'RESULT', 'citation': 'Katakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese patients at least 20 years of age\n* Patients with diagnosed primary cancer\n* Patients with metastatic lesions by CT/MRI\n\nExclusion Criteria:\n\n* Patients who have contraindication to the MRI examinations\n* Patients who have severe renal disorder\n* Patients in extremely serious general condition'}, 'identificationModule': {'nctId': 'NCT00522951', 'briefTitle': 'SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multi-center, Randomized, Controlled, Single-blind, Intra-individual Comparisons of 2 Dose of Gadobutrol 1.0 Molar and Gadoteridol (ProHance) Crossover Studies With Corresponding Blinded Image Evaluation Following Multiple Injections of 0.1 mmol/kg bw of Gadobutrol and Gadoteridol in Patients With Known or Suspected Brain Metastasis', 'orgStudyIdInfo': {'id': '91569'}, 'secondaryIdInfos': [{'id': '310864', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gadobutrol 0.1 mmol/kg bw', 'description': 'Participants received first injection (intravenous \\[i.v.\\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw', 'interventionNames': ['Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)']}, {'type': 'EXPERIMENTAL', 'label': 'Gadobutrol 0.2 mmol/kg bw', 'description': 'Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min', 'interventionNames': ['Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)']}, {'type': 'EXPERIMENTAL', 'label': 'Gadoteridol (ProHance)', 'description': 'Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min', 'interventionNames': ['Drug: ProHance']}], 'interventions': [{'name': 'Gadobutrol (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)', 'armGroupLabels': ['Gadobutrol 0.1 mmol/kg bw']}, {'name': 'Gadobutrol (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)', 'armGroupLabels': ['Gadobutrol 0.2 mmol/kg bw']}, {'name': 'ProHance', 'type': 'DRUG', 'description': 'ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)', 'armGroupLabels': ['Gadoteridol (ProHance)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-0021', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '791-0280', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '807-8555', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '060-8570', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '650-0047', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '228-8555', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '222-0036', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '583-0852', 'city': 'Habikino', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.55276, 'lon': 135.59097}}, {'zip': '583-8588', 'city': 'Habikino', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.55276, 'lon': 135.59097}}, {'zip': '589-8511', 'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'zip': '430-8558', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '411-8777', 'city': 'Sunto', 'state': 'Shizuoka', 'country': 'Japan'}, {'zip': '113-8431', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '113-8655', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'zip': '141-0022', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '683-8504', 'city': 'Yonago', 'state': 'Tottori', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 133.33333}}, {'zip': '812-8582', 'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '558-8558', 'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}