NCT05836935

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

April 19, 2023

Last Update Submit

April 29, 2023

Conditions

Keywords

Rhinosinusitiscomplicated sinusitiscomplications of sinusitisMagnetic resonance imagingComputed tompgraphyMRICT

Outcome Measures

Primary Outcomes (1)

  • Number of different Types of possible complications detected by CT and MRI

    To diagnose the diagnostic accuracy of CT and MRI in detection of different types of orbital and intracranial complications.

    6 months

Study Arms (1)

Participants

EXPERIMENTAL
Radiation: Multislice CT scan of the paranasal sinuses.Radiation: MRI examination of the paranasal sinuses

Interventions

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.

Participants

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.

Participants

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients diagnosed as sinusitis with clinically suspected complications through history and physical examination (site, onset, character of pain, constitutional symptoms, duration).

You may not qualify if:

  • Patients with absolute or relative contraindications for cross sectional imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

Location

Related Publications (5)

  • Carr TF. Complications of sinusitis. Am J Rhinol Allergy. 2016 Jul;30(4):241-5. doi: 10.2500/ajra.2016.30.4322.

    PMID: 27456592BACKGROUND
  • 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: 26307941BACKGROUND
  • 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: 22764607BACKGROUND
  • 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: 21939544BACKGROUND
  • 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.

    PMID: 19544383BACKGROUND

MeSH Terms

Conditions

RhinosinusitisAllergic Fungal SinusitisDisease

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesMycosesBacterial Infections and MycosesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohammed O Khalil, resident

CONTACT

Mohamed Th Solyman, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of radiology at sohag university hospital

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations