Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05836935
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Imaging in Complications of Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-30', 'releaseDate': '2025-01-07'}], 'estimatedResultsFirstSubmitDate': '2025-01-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096825', 'term': 'Rhinosinusitis'}, {'id': 'D000092562', 'term': 'Allergic Fungal Sinusitis'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-29', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of different Types of possible complications detected by CT and MRI', 'timeFrame': '6 months', 'description': 'To diagnose the diagnostic accuracy of CT and MRI in detection of different types of orbital and intracranial complications.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhinosinusitis', 'complicated sinusitis', 'complications of sinusitis', 'Magnetic resonance imaging', 'Computed tompgraphy', 'MRI', 'CT'], 'conditions': ['Rhinosinusitis', 'Intracranial Extension', 'Rhinosinusitis Chronic', 'Rhinosinusitis Acute', 'Fungal Sinusitis', 'Allergic Fungal Rhinosinusitis', 'Invasive Fungal Sinusitis (Diagnosis)']}, 'referencesModule': {'references': [{'pmid': '27456592', 'type': 'BACKGROUND', 'citation': 'Carr TF. Complications of sinusitis. Am J Rhinol Allergy. 2016 Jul;30(4):241-5. doi: 10.2500/ajra.2016.30.4322.'}, {'pmid': '26307941', 'type': 'BACKGROUND', 'citation': 'Marchiano E, Raikundalia MD, Carniol ET, Echanique KA, Kalyoussef E, Baredes S, Eloy JA. Characteristics of patients treated for orbital cellulitis: An analysis of inpatient data. Laryngoscope. 2016 Mar;126(3):554-9. doi: 10.1002/lary.25529. Epub 2015 Aug 26.'}, {'pmid': '22764607', 'type': 'BACKGROUND', 'citation': 'Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.'}, {'pmid': '21939544', 'type': 'BACKGROUND', 'citation': 'Chen CY, Sheng WH, Cheng A, Chen YC, Tsay W, Tang JL, Huang SY, Chang SC, Tien HF. Invasive fungal sinusitis in patients with hematological malignancy: 15 years experience in a single university hospital in Taiwan. BMC Infect Dis. 2011 Sep 22;11:250. doi: 10.1186/1471-2334-11-250.'}, {'pmid': '19544383', 'type': 'BACKGROUND', 'citation': 'Chakrabarti A, Denning DW, Ferguson BJ, Ponikau J, Buzina W, Kita H, Marple B, Panda N, Vlaminck S, Kauffmann-Lacroix C, Das A, Singh P, Taj-Aldeen SJ, Kantarcioglu AS, Handa KK, Gupta A, Thungabathra M, Shivaprakash MR, Bal A, Fothergill A, Radotra BD. Fungal rhinosinusitis: a categorization and definitional schema addressing current controversies. Laryngoscope. 2009 Sep;119(9):1809-18. doi: 10.1002/lary.20520.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the diagnostic performance of CT and MRI in the diagnosis of complications of rhinosinusitis in comparison to clinical and operative findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients diagnosed as sinusitis with clinically suspected complications through history and physical examination (site, onset, character of pain, constitutional symptoms, duration).\n\nExclusion Criteria:\n\n* Patients with absolute or relative contraindications for cross sectional imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.'}, 'identificationModule': {'nctId': 'NCT05836935', 'briefTitle': 'Role of Imaging in Complications of Sinusitis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Role of Imaging in Complications of Sinusitis.', 'orgStudyIdInfo': {'id': 'Soh-Med-23-04-02MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'interventionNames': ['Radiation: Multislice CT scan of the paranasal sinuses.', 'Radiation: MRI examination of the paranasal sinuses']}], 'interventions': [{'name': 'Multislice CT scan of the paranasal sinuses.', 'type': 'RADIATION', 'description': 'MSCT scan using GE Revolution Evo 128 multidetector elements scanner (GE Healthcare, Chicago, Illinois, United state) , Toshiba Alexion 16 detector elements scanner (Aplio 500, Toshiba Medical Systems, Otawara-shi, Tochigi 324-8550, Japan). Or Canon Aquilion Prime SP 160 -multidetector- row CT scanner (Canon Medical Systems, Tochigi, Japan) Thin slice Axial scans will be taken at 0.625-1.0 mm slice thickness, commencing from the hard palate till above the end of frontal sinuses, coronal and sagittal multiplanar reconstruction images will be obtained.', 'armGroupLabels': ['Participants']}, {'name': 'MRI examination of the paranasal sinuses', 'type': 'RADIATION', 'description': 'MRI imaging using Philips Achieva 1.5T MRI device (Philips Achieva, Netherlands) or Siemens Magnetom Altea 1.5T MRI device (Siemens Healthineers, Germany) for suspected intracranial and orbital complications.', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag University hospitals', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohammed O Khalil, resident', 'role': 'CONTACT', 'email': 'mohamedkhalil@med.sohag.edu.eg', 'phone': '+201001272453'}, {'name': 'Mohamed Th Solyman, Professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of radiology at sohag university hospital', 'investigatorFullName': 'Mohamed Osama Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-01-07', 'type': 'RELEASE'}, {'date': '2025-01-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamed Osama Mohamed, Resident of radiology at sohag university hospital, Sohag University'}}}}