Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00323102
Status:
COMPLETED
Last Update Posted:
2008-01-23
First Post:
2006-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C064572', 'term': 'gadobenic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-18', 'studyFirstSubmitDate': '2006-05-05', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superiority of Multihance in terms of by-patient global diagnostic performance', 'timeFrame': 'immediately post dose'}], 'secondaryOutcomes': [{'measure': 'To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions', 'timeFrame': 'immediately post dose'}, {'measure': 'To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity', 'timeFrame': 'immediately post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Pathology']}, 'descriptionModule': {'briefSummary': 'This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days\n\nExclusion Criteria:\n\n* Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams'}, 'identificationModule': {'nctId': 'NCT00323102', 'acronym': 'ENHANCE', 'briefTitle': 'A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bracco Diagnostics, Inc'}, 'officialTitle': 'Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain', 'orgStudyIdInfo': {'id': 'MH 130'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Multihance', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bracco Diagnostics, Inc.', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Barry Hogstrom, M. D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bracco Diagnostics, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}}}}