Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00415805
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2006-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C064572', 'term': 'gadobenic acid'}, {'id': 'C109932', 'term': 'gadofosveset trisodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2006-12-22', 'studyFirstSubmitQcDate': '2006-12-23', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity compared to DSA', 'timeFrame': 'post dose'}], 'secondaryOutcomes': [{'measure': 'accuracy and predictive values; inter-reader agreement for diagnostic performance', 'timeFrame': 'post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Steno-occlusive Disease']}, 'descriptionModule': {'briefSummary': 'This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known or suspected renovascular disease based on one of the following criteria:\n\n * severe hypertension\n * hypertension refractory to standard therapy\n * abrupt onset of moderate to severe hypertension at age \\< 35 years\n * normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension\n * unexplained by stable elevation of serum creatinine \\> 2Mg/dL\n * positive findings for stenosis from another imaging modality'}, 'identificationModule': {'nctId': 'NCT00415805', 'briefTitle': 'Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bracco Diagnostics, Inc'}, 'officialTitle': 'A Pilot, Open-label, Multicenter Intra-individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries', 'orgStudyIdInfo': {'id': 'MH 128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Multihance']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: vasovist']}], 'interventions': [{'name': 'Multihance', 'type': 'DRUG', 'description': '0.5 Molar, single injection at 0.2 mL/kg', 'armGroupLabels': ['1']}, {'name': 'vasovist', 'type': 'DRUG', 'description': '0.25 molar single injection 0.03 ml/kg', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20134', 'city': 'Milan', 'country': 'Italy', 'facility': 'Bracco Imaging, S.p.A', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Gianpaolo Pirovano, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bracco Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}