Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT03619694
Status:
UNKNOWN
Last Update Posted:
2018-08-08
First Post:
2018-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of MR Spectroscopy in Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2018-08-03', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of MRS findings with the pathology of the specimens', 'timeFrame': 'Baseline', 'description': 'Analysis of the MRS metabolites peaks and integral and test if they can differentiate the grades of brain tumors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Neoplasms']}, 'referencesModule': {'references': [{'pmid': '28667395', 'type': 'BACKGROUND', 'citation': 'Peitgen N, Papanagiotou P. [Intra-axial brain tumors in adults : On the basis of the 2016 WHO classification]. Radiologe. 2017 Sep;57(9):707-714. doi: 10.1007/s00117-017-0271-6. German.'}, {'pmid': '28640699', 'type': 'BACKGROUND', 'citation': 'Brindle KM, Izquierdo-Garcia JL, Lewis DY, Mair RJ, Wright AJ. Brain Tumor Imaging. J Clin Oncol. 2017 Jul 20;35(21):2432-2438. doi: 10.1200/JCO.2017.72.7636. Epub 2017 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'In order to come as close as possible to the correct diagnosis of CNS tumors, MRI is the long-standing accepted method of choice that can in some cases be supported by the use of CT to demonstrate calcification or bone destruction. In individual cases MRI spectroscopy can be helpful for the differentiation between neoplasms and inflammatory lesions or surveillance of tumor therapy, just as perfusion', 'detailedDescription': 'Proton magnetic resonance spectroscopy (H-MRS) may be helpful in suggesting tumor histology and tumor grade and may better define tumor extension and the ideal site for biopsy compared with conventional magnetic resonance (MR) imaging. A multifunctional approach with diffusion-weighted imaging, perfusion-weighted imaging, and permeability maps, along with H-MRS, may enhance the accuracy of the diagnosis and characterization of brain tumors and estimation of therapeutic response. Integration of advanced imaging techniques with conventional MR imaging and the clinical history help to improve the accuracy, sensitivity, and specificity in differentiating tumors and nonneoplastic lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with brain tumors diagnosed by conventional imaging', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with space-occupying lesions\n\nExclusion Criteria:\n\n* Post operative cases\n* Non-neoplastic nature'}, 'identificationModule': {'nctId': 'NCT03619694', 'briefTitle': 'Role of MR Spectroscopy in Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Magnetic Resonance Spectroscopy in Differentiating Brain Tumors', 'orgStudyIdInfo': {'id': 'MRS in brain tumors'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI Spectroscopy', 'type': 'DEVICE', 'description': 'Patient with brain SOL underwent MRI Spectroscopy to be compared with later pathology'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed AbdelWahab, Msc', 'role': 'CONTACT', 'email': 'dr.assiut@gmail.com', 'phone': '01148918822', 'phoneExt': '+20'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohamed Abdelwahab', 'investigatorAffiliation': 'Assiut University'}}}}