Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT05801393
Status:
UNKNOWN
Last Update Posted:
2023-04-06
First Post:
2023-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HRCT, CT Cisternography and MR Cisternography in Assessment of CSF Rhinorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-25', 'studyFirstSubmitDate': '2023-03-25', 'studyFirstSubmitQcDate': '2023-03-25', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.', 'timeFrame': 'from May 2023 to January 2025', 'description': 'Patients with persistent or intermittent CSF rhinorrhea will be scanned after a full clinical history with Oto-laryngological examination to confirm the presence of CSF leak'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Imaging of Active CSF Rhinorrhea']}, 'descriptionModule': {'briefSummary': 'To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.', 'detailedDescription': 'CSF rhinorrhea is defined as passage of CSF from the subarachnoid space through osseous and dural defect at skull base into the nasal cavity.\n\nCauses of CSF rhinorrhea are classified into traumatic (including iatrogenic) and non traumatic (including spontaneous leak).\n\nPatients are presented by variable symptoms including clear nasal discharge, headache or with complications like meningitis or even brain abscess, so closure of the defect is of great importance with required accurate localization of the defect and its dimensions.\n\nCSF rhinorrhea can be also classified into active when with active dripping or inactive when dripping is intermittent.\n\nDifferent imaging modalities have been employed to localize and characterize skull base defects responsible for CSF leakage including computed tomography (CT), CT cisternography (CTC), magnetic resonance imaging (MRI), MR cisternography (MRC) and radionuclide cisternography (RNC). However, there is still no gold standard imaging modality.\n\nHigh resolution computed tomography (HRCT) provides accurate bone details, but difficult to differentiate para nasal sinus secretions from CSF leak. contrast enhancing CT cisternography has an advantage of definite proof of CSF leak and definite anatomical localization of the bony defect, but side effects like headache and meningeal irritation may occur.\n\nMagnetic resonance imaging (MRI) with 3D- constructive interference in steady state (3D-CISS) (MR cisternography) instead of the invasive CT cisternography shows CSF as a bright signal without intra thecal contrast injection. Also MRI provides intra cranial details, but it lacks of bony details.\n\nIn the present prospective study, we will assess the use of HRCT, CTC and MRC imaging modalities in definite diagnosis and localization of active CSF leak.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 patients with active CSF rhinorrhea, no age limits', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) patients with active traumatic or non traumatic CSF leakage.\n* (2) patients with adequate organ function.\n\nExclusion Criteria:\n\n* (1) Patients known to have contrast hypersensitivity. (2) Patients with any general contraindication to MRI as presence of para magnetic substance as pacemakers or with claustrophobia.\n\n (3) Patients with contraindication to lumbar puncture:\n * Infection near the puncture site, fever, sepsis.\n * New focal neurological signs or seizures.\n * Increased intra cranial tension.\n * Space occupying lesion.\n * Vertebral deformity, retropulsion, severe vertebral osteoarthritis or degenerative disc disease renders procedures more technically difficult.\n * Coagulopathy.\n * Patient refusal.'}, 'identificationModule': {'nctId': 'NCT05801393', 'briefTitle': 'HRCT, CT Cisternography and MR Cisternography in Assessment of CSF Rhinorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Combined HRC, CT Cisternography and MR Cisternography in Assessment of Active CSF Rhinorrhes Compared to Operative Findings', 'orgStudyIdInfo': {'id': 'cisternography CSF rhinorrhea'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT, MRI', 'type': 'RADIATION', 'description': 'HRCT with no IV contrast administration and bone algorithm. Intra thecal injection of contrast, then CT in prone position to obtain direct coronal cuts.\n\nMR cisternography using a three dimensional constructive interference in steady state (3D-CISS) sequence.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ghada A Mohamed', 'role': 'CONTACT', 'email': 'ae476647@gmail.com', 'phone': '01141729468'}, {'name': 'Hazem AZ Yousef', 'role': 'CONTACT', 'email': 'bozaidahzz@yahoo.com', 'phone': '01005075888'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'GAMohamed', 'investigatorFullName': 'Ghada Abdelsabour Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}