Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-01 @ 9:19 PM
Study NCT ID:
NCT01394692
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2011-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'c.senft@med.uni-frankfurt.de', 'phone': '+49 69 63015939', 'title': 'Dr. Christian Senft', 'organization': 'Johann Wolfgang Goethe University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intraoperative MRI', 'description': 'tumor resection with intraoperative MRI-guidance', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Group', 'description': 'standard microsurgical tumor resection', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Extent of Resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative MRI', 'description': 'tumor resection with intraoperative MRI-guidance'}, {'id': 'OG001', 'title': 'Conventional Group', 'description': 'standard microsurgical tumor resection'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'timeFrame': '6 months', 'description': 'Progression-free survival (radiological and/or clinical progression) at 6 months following surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Volumetric Assessment', 'timeFrame': '72 hours', 'description': 'Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Neurological Deficit', 'timeFrame': '7 days', 'description': 'Assessment of new postoperative deficits following tumor surgery', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intraoperative MRI', 'description': 'tumor resection with intraoperative MRI-guidance'}, {'id': 'FG001', 'title': 'Conventional Group', 'description': 'standard microsurgical tumor resection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intraoperative MRI', 'description': 'tumor resection with intraoperative MRI-guidance'}, {'id': 'BG001', 'title': 'Conventional Group', 'description': 'standard microsurgical tumor resection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '13', 'groupId': 'BG000'}, {'value': '58', 'spread': '13', 'groupId': 'BG001'}, {'value': '58', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-29', 'studyFirstSubmitDate': '2011-07-13', 'resultsFirstSubmitDate': '2012-09-20', 'studyFirstSubmitQcDate': '2011-07-13', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-29', 'studyFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extent of Resection', 'timeFrame': '72 hours', 'description': 'Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': '6 months', 'description': 'Progression-free survival (radiological and/or clinical progression) at 6 months following surgery'}, {'measure': 'Volumetric Assessment', 'timeFrame': '72 hours', 'description': 'Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI'}, {'measure': 'Neurological Deficit', 'timeFrame': '7 days', 'description': 'Assessment of new postoperative deficits following tumor surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intraoperative MRI', 'glioma surgery', 'extent of resection'], 'conditions': ['Glioma']}, 'referencesModule': {'references': [{'pmid': '21868284', 'type': 'RESULT', 'citation': 'Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.\n\nIn order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.\n\nProspective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known or suspected contrast-enhancing glioma (primary and recurrent)\n* location of the tumor permits intended gross-total resection\n\nExclusion Criteria:\n\n* tumor location prohibits or questions gross-total resection\n* contraindications to undergo MRI examinations'}, 'identificationModule': {'nctId': 'NCT01394692', 'briefTitle': 'Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI', 'orgStudyIdInfo': {'id': 'JWG-EK 239/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intraoperative MRI', 'description': 'tumor resection with intraoperative MRI-guidance', 'interventionNames': ['Procedure: intraoperative MRI-guided tumor resection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional group', 'description': 'standard microsurgical tumor resection', 'interventionNames': ['Procedure: standard microsurgery']}], 'interventions': [{'name': 'intraoperative MRI-guided tumor resection', 'type': 'PROCEDURE', 'otherNames': ['PoleStar-N20 intraoperative MRI'], 'description': 'tumor resection with the use of an intraoperative MRI', 'armGroupLabels': ['intraoperative MRI']}, {'name': 'standard microsurgery', 'type': 'PROCEDURE', 'description': 'microsurgical tumor resection', 'armGroupLabels': ['conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60528', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Department of Neurosurgery, Goethe-University', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Christian Senft, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University'}, {'name': 'Volker Seifert, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Goethe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurosurgeon', 'investigatorFullName': 'Christian Senft', 'investigatorAffiliation': 'Goethe University'}}}}