Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT01010932
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2009-11-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072417', 'term': 'gadoterate meglumine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pierre.desche@guerbet-group.com', 'phone': '+33 1 45 91 50 00', 'title': 'Dr Pierre Desché, MD - VP Head of Development, Medical and Regulatory Affairs', 'organization': 'Guerbet'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.', 'description': 'Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Dotarem MRA', 'description': 'Patients benefiting from a MR angiography after an IV administration of Dotarem', 'otherNumAtRisk': 200, 'otherNumAffected': 12, 'seriousNumAtRisk': 200, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'TOF MRA', 'description': 'Patients benefiting from a MR angiography with no contrast medium administration', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Computerized Tomography Angiography (CTA)', 'description': 'Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium', 'otherNumAtRisk': 200, 'otherNumAffected': 7, 'seriousNumAtRisk': 200, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Patients Discontinued Without Dotarem Administration', 'description': 'Patients withdrawn before administration of Dotarem whatever the reason', 'otherNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil Count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Carotid artery stenosis', 'notes': 'not related to Dotarem administration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'notes': 'not related to Dotarem administration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'notes': 'not related to Dotarem administration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'notes': 'not related to Dotarem administration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Technical Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}, {'units': 'arterial segments', 'counts': [{'value': '2772', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem-enhanced MRA', 'description': 'Patients benefiting from an MRA after Dotarem IV administration'}, {'id': 'OG001', 'title': 'TOF MRA', 'description': 'Patients benefiting from an MRA with no contrast medium administration'}], 'classes': [{'title': 'Reader 1', 'categories': [{'measurements': [{'value': '4.65', 'groupId': 'OG000', 'lowerLimit': '3.87', 'upperLimit': '5.44'}, {'value': '29.44', 'groupId': 'OG001', 'lowerLimit': '27.74', 'upperLimit': '31.13'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '1.77', 'groupId': 'OG000', 'lowerLimit': '1.28', 'upperLimit': '2.26'}, {'value': '16.70', 'groupId': 'OG001', 'lowerLimit': '15.31', 'upperLimit': '18.09'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '2.20', 'groupId': 'OG000', 'lowerLimit': '1.65', 'upperLimit': '2.75'}, {'value': '18.54', 'groupId': 'OG001', 'lowerLimit': '17.10', 'upperLimit': '19.99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 - 28 days', 'description': 'Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).', 'unitOfMeasure': 'percentage of arterial segments', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'arterial segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'For 2 patients, MRA images were not analyzed because images were incomplete.'}, {'type': 'PRIMARY', 'title': 'Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}, {'units': 'number of arterial segments', 'counts': [{'value': '2686', 'groupId': 'OG000'}, {'value': '2686', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem-enhanced MRA', 'description': 'Patients benefiting from an MRA after Dotarem IV administration'}, {'id': 'OG001', 'title': 'TOF MRA', 'description': 'Patients benefiting from an MRA with no contrast medium administration'}], 'classes': [{'title': 'Reader 1', 'categories': [{'measurements': [{'value': '58.46', 'groupId': 'OG000', 'lowerLimit': '46.48', 'upperLimit': '70.44'}, {'value': '53.85', 'groupId': 'OG001', 'lowerLimit': '41.73', 'upperLimit': '65.97'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '63.08', 'groupId': 'OG000', 'lowerLimit': '51.34', 'upperLimit': '74.81'}, {'value': '63.08', 'groupId': 'OG001', 'lowerLimit': '51.34', 'upperLimit': '74.81'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '53.85', 'groupId': 'OG000', 'lowerLimit': '41.73', 'upperLimit': '65.97'}, {'value': '49.23', 'groupId': 'OG001', 'lowerLimit': '37.08', 'upperLimit': '61.38'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-42 days', 'description': 'Rate of true stenotic segments (i.e. with stenosis \\>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).', 'unitOfMeasure': 'percentage of stenotic segments', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of arterial segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.'}, {'type': 'PRIMARY', 'title': 'Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}, {'units': 'Number of arterial segments', 'counts': [{'value': '2686', 'groupId': 'OG000'}, {'value': '2686', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem-enhanced MRA', 'description': 'Patients benefiting from an MRA after Dotarem IV administration'}, {'id': 'OG001', 'title': 'TOF MRA', 'description': 'Patients benefiting from an MRA with no contrast medium administration'}], 'classes': [{'title': 'Reader 1', 'categories': [{'measurements': [{'value': '98.13', 'groupId': 'OG000', 'lowerLimit': '97.61', 'upperLimit': '98.65'}, {'value': '85.43', 'groupId': 'OG001', 'lowerLimit': '84.07', 'upperLimit': '86.78'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '98.51', 'groupId': 'OG000', 'lowerLimit': '98.05', 'upperLimit': '98.98'}, {'value': '90.39', 'groupId': 'OG001', 'lowerLimit': '89.26', 'upperLimit': '91.51'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '98.63', 'groupId': 'OG000', 'lowerLimit': '98.18', 'upperLimit': '99.07'}, {'value': '90.42', 'groupId': 'OG001', 'lowerLimit': '89.30', 'upperLimit': '91.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 - 42 days', 'description': 'Rate of true non-stenotic segments (i.e. without stenosis \\>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).', 'unitOfMeasure': 'percentage of non-stenotic segments', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of arterial segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TOF MRA Followed by Dotarem-enhanced MRA', 'description': 'Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.\n\nEach patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'First patient first visit: 21 Sep 2009. Last patient last visit: 18 Nov 2010. Location: radiology departments', 'preAssignmentDetails': 'A total of 222 patients fulfilling the eligibility criteria were enrolled, of which 200 patients received Dotarem and completed the study. Twenty-two patients did not receive Dotarem and were discontinued prematurely.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TOF MRA Followed by Dotarem-enhanced MRA', 'description': 'Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.\n\nEach patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '11.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'dispFirstSubmitDate': '2012-11-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2009-11-09', 'dispFirstSubmitQcDate': '2012-11-09', 'resultsFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2009-11-09', 'dispFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-29', 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Failure Rate', 'timeFrame': '2 - 28 days', 'description': 'Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).'}, {'measure': 'Sensitivity', 'timeFrame': '2-42 days', 'description': 'Rate of true stenotic segments (i.e. with stenosis \\>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).'}, {'measure': 'Specificity', 'timeFrame': '2 - 42 days', 'description': 'Rate of true non-stenotic segments (i.e. without stenosis \\>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carotid or vertebral artery disease', 'Contrast agent', 'MRA'], 'conditions': ['Cerebral Arterial Diseases']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.', 'detailedDescription': 'Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged more than 18 years\n* Strongly suspected of having carotid or vertebral arterial disease\n* Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination\n\nExclusion Criteria:\n\n* Known grade IV or V chronic kidney disease (GFR\\<30 mL/min/1.73m²)\n* Contraindication to MRI\n* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination'}, 'identificationModule': {'nctId': 'NCT01010932', 'briefTitle': 'Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guerbet'}, 'officialTitle': 'Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease', 'orgStudyIdInfo': {'id': 'DGD-44-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dotarem and TOF MRA', 'description': 'Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.', 'interventionNames': ['Drug: Dotarem', 'Other: TOF MRA']}], 'interventions': [{'name': 'Dotarem', 'type': 'DRUG', 'otherNames': ['Gadoterate meglumine'], 'description': 'Each subject will receive one injection of Dotarem 0.2ml/kg', 'armGroupLabels': ['Dotarem and TOF MRA']}, {'name': 'TOF MRA', 'type': 'OTHER', 'description': 'Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)', 'armGroupLabels': ['Dotarem and TOF MRA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47403', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Guerbet LLC', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'overallOfficials': [{'name': 'Pierre DESCHE, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guerbet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guerbet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}