Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-07 @ 10:43 PM
Study NCT ID:
NCT03531333
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Gross total resection (yes/no) on post-operative T1 postcontrast MRI scans will be evaluated by a neuroradiologist who is blinded for the treatment arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.\n\nThe study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2018-05-09', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross total resection (Yes or No)', 'timeFrame': 'within 48 hours after surgery', 'description': 'Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.'}], 'secondaryOutcomes': [{'measure': 'Extent of resection (%)', 'timeFrame': 'within 48 hours after surgery', 'description': 'as a continous variable The extent of resection (%) is a secondary outcome measurement defined as the residual tumor volumes on post-operative MRI studies compared to the operative tumor volume.'}, {'measure': 'Neurological outcome (Karnofsky Performance status)', 'timeFrame': 'within 1 week after surgery', 'description': 'Karnofsky Performance status'}, {'measure': 'Quality of Life (QLQ C30 questionnaires)', 'timeFrame': '1, 3 and 6 months after surgery', 'description': 'QLQ C30 questionnaires\n\nA brain tumor specific quality of life measurement tool'}, {'measure': 'Quality of Life (QLQ BN20 questionnaires)', 'timeFrame': '1, 3 and 6 months after surgery', 'description': 'QLQ BN20 questionnaires\n\nA brain tumor specific quality of life measurement tool'}, {'measure': 'Surgery associated neurological deficits (National Institutes of Health Stroke Scale)', 'timeFrame': '1 month after surgery', 'description': 'National Institutes of Health Stroke Scale\n\n0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke\n\nNIHSS is a tool used by healthcare providers to objectively quantify the impairment caused typically by a stroke, however it is also used for tumor studies to assess functioning on the level of speech, motor and sensory functions.'}, {'measure': 'Survival (time in days)', 'timeFrame': 'status will be checked 15 months after surgery', 'description': 'time measured from surgery until death in days.\n\nThis study has a follow up of 6 months. However, when patients are alive at months after surgery, we will contact the general practictioner of the patient 15 months after the trial to obtain survival data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glioma, intraoperative ultrasound, gross total resection, quality of life'], 'conditions': ['Glioma']}, 'referencesModule': {'references': [{'pmid': '34094939', 'type': 'DERIVED', 'citation': 'Incekara F, Smits M, Dirven L, Bos EM, Balvers RK, Haitsma IK, Schouten JW, Vincent AJPE. Intraoperative B-Mode Ultrasound Guided Surgery and the Extent of Glioblastoma Resection: A Randomized Controlled Trial. Front Oncol. 2021 May 19;11:649797. doi: 10.3389/fonc.2021.649797. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.', 'detailedDescription': 'Study design:\n\nThe US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.\n\nStudy population:\n\nFifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan.\n\nIntervention:\n\nThe study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .\n\nMain study parameters/endpoints:\n\n* Gross total resection (yes/no)\n* Extent of resection (%)\n* Neurological outcome (Karnofsky Performance Status)\n* Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire)\n* Surgery associated neurological deficits (National Institutes of Health Stroke Scale)\n* Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0)\n* Survival time (days)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals of 18 years or older\n* Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma\n* KPS ≥ 60\n* Preoperative intention to perform gross-total resection of the enhancing tumor\n* Written informed consent conform ICH-GCP\n\nExclusion Criteria:\n\n* Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection\n* Multifocal contrast enhancing lesions\n* Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke)\n* Inability to give consent because of dysphasia or language barrier'}, 'identificationModule': {'nctId': 'NCT03531333', 'acronym': 'US-GLIOMA', 'briefTitle': 'Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.', 'orgStudyIdInfo': {'id': 'MEC-2015-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound', 'description': 'ultrasound navigation guided surgery.', 'interventionNames': ['Procedure: ultrasound guided surgery.']}, {'type': 'NO_INTERVENTION', 'label': 'Non-ultrasound', 'description': 'standard surgery without ultrasound guidance.'}], 'interventions': [{'name': 'ultrasound guided surgery.', 'type': 'PROCEDURE', 'description': 'during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.', 'armGroupLabels': ['Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stichting Coolsingel', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'neurosurgeon, principal investigator', 'investigatorFullName': 'A.J.P.E. VIncent', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}