Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT03608605
Status:
UNKNOWN
Last Update Posted:
2018-08-01
First Post:
2018-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced MRI Sequences in Multiple Sclerosis and Its Mimics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'role of advanced MRI sequences in establishing the diagnosis of multiple sclerosis(MS)', 'timeFrame': 'baseline', 'description': 'calculating the sensitivity,specificity and accuracy of diffusion tensor imaging (DTI) and dual inversion recovery(DIR) in differentiating MS from its mimics'}], 'secondaryOutcomes': [{'measure': 'follow up of MS patients after one year of treatment', 'timeFrame': 'one year', 'description': 'assess the degree of brain atrophy after one year mainly in the white matter and cerebral cortex using 3DT1WI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'We aim to evaluate the role of conventional and advanced MRI sequences in:\n\n1. Establishing the diagnosis of multiple sclerosis and differentiate it from its mimics.\n2. Predict the prognosis and evaluate the treatment response in the first year of patients with multiple sclerosis.', 'detailedDescription': "All patients in the study will be referred among those attend to Assuit university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).\n\nMRI study will be done for each patient. MRI study will be repeated for those already diagnosed as MS after starting the suitable treatment as decided by attending physician after one year to assess the efficacy of treatment and the patient prognosis.\n\nMR imaging will be performed on a 1.5-T MR imaging unit (Siemens, Sembra medical system,German).\n\nProspectively completed data forms will be analyzed and compared. Statistical tests appropriate to the nature of the data will be used.\n\nAll patients will not be subjected to risk of any kind during this study. All patients' data will be confidentially kept. Approval of the ethical committee of Faculty of Medicine, Assiut University.\n\nAn informed consent will be taken from all patients included in this study.\n\n* The research will be conducted only by scientifically qualified and trained personnel.\n* The procedures included in this study have been already used in hospital and centers in and outside Egypt."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients among those attend to Assiut university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients in the study will be referred among those attend to Assuit university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).\n\nExclusion Criteria:\n\n* o Any general contraindication of MRI in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia.\n\n * Patient above 50 years old.'}, 'identificationModule': {'nctId': 'NCT03608605', 'acronym': 'MS', 'briefTitle': 'Advanced MRI Sequences in Multiple Sclerosis and Its Mimics', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Advanced MRI Sequences in Differentiating MS and Its Mimics', 'orgStudyIdInfo': {'id': '17200227'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'magnetic resonance imaging with advanced sequences including tractography,volumetry and inversion recovery'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'samaa el-kossi, master', 'role': 'CONTACT', 'email': 'samaa.mostafa12330@gmail.com', 'phone': '01028820033'}, {'name': 'gehan sayed, doctorate', 'role': 'CONTACT', 'email': 'gehanseif@yahoo.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant lecturer', 'investigatorFullName': 'Samaa Mostafa El-kossi', 'investigatorAffiliation': 'Assiut University'}}}}