Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT00845702
Status:
TERMINATED
Last Update Posted:
2016-05-20
First Post:
2009-02-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive 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': 'Pierre Desche, MD, Head of Clinical and Regulatory Affairs', 'organization': 'Guerbet'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was not completed due to poor enrollment. The statistical analysis was not performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dotarem Magnetic Resonance Angiography', 'description': 'Each subject will receive one injection of Dotarem 0.2 ml/kg.', 'otherNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Time Of Flight MRA', 'description': 'Subjects undergo a TOF MRA', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Investigation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Mental status changed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Non Assessable Renal Artery Segments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem MRA', 'description': 'Each subject will receive one injection of Dotarem 0.2 ml/kg.'}, {'id': 'OG001', 'title': 'Time Of Flight MRA', 'description': 'Each subject will undergo a TOF MRA'}], 'timeFrame': '1 to 7 days', 'description': 'For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared', 'reportingStatus': 'POSTED', 'populationDescription': 'The study has been prematurely terminated, and the planned analyses were not done'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TOF Followed by Dotarem-enhanced MRA', 'description': 'Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).'}], 'periods': [{'title': 'TOF MRA', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient did not perform study MRA procedures.', 'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Dotarem MRA', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Patient First Visit: Apr 2009 Last Patient Last Visit: Feb 2010 Location: Radiology centers', 'preAssignmentDetails': 'Out of the 33 enrolled patients, one patient did not undergo any of the planned procedures due to an inability to obtain an intravenous access with the initial planned procedure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TOF and Dotarem Enhanced MRA', 'description': 'Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline measures were recorded for all 33 patients.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'lack of recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2009-02-16', 'resultsFirstSubmitDate': '2011-09-22', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-18', 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Non Assessable Renal Artery Segments', 'timeFrame': '1 to 7 days', 'description': 'For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal artery stenosis', 'Contrast agent', 'MRA'], 'conditions': ['Renal Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.', 'detailedDescription': 'Each participant will undergo first a TOF 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 renal arterial disease,\n* Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography 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': 'NCT00845702', 'briefTitle': 'Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guerbet'}, 'officialTitle': 'Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease', 'orgStudyIdInfo': {'id': 'DGD-44-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dotarem', 'description': 'Each subject will receive one injection of Dotarem 0.2 ml/kg.', 'interventionNames': ['Drug: Gadoterate meglumine (Dotarem)']}, {'type': 'OTHER', 'label': 'Time Of Flight Magnetic Resonance Angiography', 'description': 'Each subject undergo a TOF MRA', 'interventionNames': ['Other: Time of Flight Magnetic Resonance Angiography']}], 'interventions': [{'name': 'Gadoterate meglumine (Dotarem)', 'type': 'DRUG', 'description': 'Each subject will receive one injection of Dotarem 0.2 ml/kg', 'armGroupLabels': ['Dotarem']}, {'name': 'Time of Flight Magnetic Resonance Angiography', 'type': 'OTHER', 'description': 'Each subject will undergo a TOF MRA', 'armGroupLabels': ['Time Of Flight Magnetic Resonance Angiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47403', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Guerbet LLC', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guerbet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}