Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:52 PM
Study NCT ID:
NCT02540967
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Use Investigation of Gadovist.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C090600', 'term': 'gadobutrol'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3357}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of episodes of adverse events as a measure of safety and tolerability', 'timeFrame': 'Up to 3 days'}], 'secondaryOutcomes': [{'measure': 'Number of episodes of adverse drug reactions and adverse events', 'timeFrame': 'Up to 3 days', 'description': 'In subpopulations'}, {'measure': 'Contrast enhancement', 'timeFrame': 'At the time of MRI', 'description': 'Investigator Discretion as very improved , improved, not changed, degraded, not evaluable.\n\nMRI- Magnetic Resonance Imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Contrast enhancement in the following MR imaging', 'Brain and spine', 'Body and extremities', 'Gadobutrol'], 'conditions': ['Magnetic Resonance Imaging', 'Image Enhancement']}, 'referencesModule': {'references': [{'pmid': '30232584', 'type': 'RESULT', 'citation': 'Tsushima Y, Awai K, Shinoda G, Miyoshi H, Chosa M, Sunaya T, Endrikat J. Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. Jpn J Radiol. 2018 Nov;36(11):676-685. doi: 10.1007/s11604-018-0778-4. Epub 2018 Sep 19.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Description: Click here to find results for studies related to Bayer products.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to investigate the safety and effectiveness of Gadovist.', 'detailedDescription': 'This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).\n\nThe study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.\n\nFor each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male patients who planned Gd contrast enhanced MRI in accordance with approved label. Eligible patients who receive Gadovist will be enrolled and documented in the eCRF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.\n\nExclusion Criteria:\n\n* Patients who are contraindicated based on approved label.'}, 'identificationModule': {'nctId': 'NCT02540967', 'briefTitle': 'Drug Use Investigation of Gadovist.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Drug Use Investigation of Gadovist', 'orgStudyIdInfo': {'id': '17512'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BAY86-4875', 'description': 'Gadovist administration goup', 'interventionNames': ['Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)']}], 'interventions': [{'name': 'Gadobutrol (Gadavist/Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Gadovist dosage following summary of product characteristics', 'armGroupLabels': ['BAY86-4875']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Many Locations'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}