Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-28 @ 4:47 PM
Study NCT ID:
NCT03166592
Status:
UNKNOWN
Last Update Posted:
2017-08-16
First Post:
2017-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance in Adults
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': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-13', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with malignant masses', 'timeFrame': '1 hour', 'description': 'sensitivity of the magnetic resonance spectroscopy in diagnosis of brain malignant masses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Tumor']}, 'descriptionModule': {'briefSummary': 'Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit.\n\nContrast enhancement reflects only disruption of blood brain barrier. One third of high-grade malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement.\n\nReliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade from low grade tumor, is difficult with conventional Magnetic resonance imaging'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Magnetic resonance imaging detected brain cases referred from Neurosurgery \\& Neuropsychiatry departments as well as Outpatient clinics', 'eligibilityCriteria': '1. Inclusion criteria:\n\n \\* An intra axial space occupying lesion/lesions detected on conventional structural imaging\n2. Exclusion criteria:\n\n * MRI contraindications (as pace maker or claustrophobia).\n * Contrast hypersensitivity\n * Impaired renal function.\n * Pediatric age group'}, 'identificationModule': {'nctId': 'NCT03166592', 'briefTitle': 'Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Advanced Neuroimaging Techniques in Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance Diagnostic Strategy in Adults', 'orgStudyIdInfo': {'id': 'IAM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic resonance imaging with contrast', 'type': 'DEVICE', 'description': 'injection of gadolinium contrast then acquisition of images with magnetic resonance imaging then spectroscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed abbas, MD', 'role': 'CONTACT', 'email': 'bmr90@hotmail.com'}, {'name': 'ahmed abbas', 'role': 'CONTACT'}], 'facility': 'Ahmed Abbas'}, {'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Abbas, MD', 'role': 'CONTACT', 'email': 'bmr90@hotmail.com', 'phone': '00201003385183'}], 'facility': 'Assiut Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmed Abbas, MD', 'role': 'CONTACT', 'email': 'bmr90@hotmail.com', 'phone': '00201003385183'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}