RhinosinusitisNCT05836935
Role of Imaging in Complications of Sinusitis
A study testing Multislice CT scan of the paranasal sinuses. and MRI examination of the paranasal sinuses in people with Rhinosinusitis and Intracranial Extension, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Rhinosinusitis, Intracranial Extension, Rhinosinusitis Chronic
- What is being tested?
- Multislice CT scan of the paranasal sinuses. and MRI examination of the paranasal sinuses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients diagnosed as sinusitis with clinically suspected complications through history and physical examination (site, onset, character of pain, constitutional symptoms, duration).
Who cannot join
- Patients with absolute or relative contraindications for cross sectional imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
Trial locations and contacts
1 site in 1 country.
Mohamed Th Solyman, Professor contact
About this study
Official title: Role of Imaging in Complications of Sinusitis.
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.
- Conditions
- Rhinosinusitis, Intracranial Extension, Rhinosinusitis Chronic, Rhinosinusitis Acute, Fungal Sinusitis, Allergic Fungal Rhinosinusitis
- Being tested
- Multislice CT scan of the paranasal sinuses., MRI examination of the paranasal sinuses
- Keywords
- Rhinosinusitis, complicated sinusitis, complications of sinusitis, Magnetic resonance imaging, Computed tompgraphy, MRI, CT
- Medical subject headings
- Rhinosinusitis, Allergic Fungal Sinusitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multislice CT scan of the paranasal sinuses.Radiation
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.
MRI examination of the paranasal sinusesRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Not described Receives: Radiation: Multislice CT scan of the paranasal sinuses.; Radiation: MRI examination of the paranasal sinuses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study startMay 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osama Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836935
- Sponsor's protocol ID
- Soh-Med-23-04-02MS
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carr TF. Complications of sinusitis. Am J Rhinol Allergy. 2016 Jul;30(4):241-5. doi: 10.2500/ajra.2016.30.4322.
PubMed 27456592Marchiano 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.
PubMed 26307941Fokkens 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.
PubMed 22764607Chen 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.
PubMed 21939544Chakrabarti 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.
PubMed 19544383
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Imaging in Complications of Sinusitis.
- ClinicalTrials.gov ID
- NCT05836935
- Acronym / sponsor ID
- Soh-Med-23-04-02MS
- Conditions
- Rhinosinusitis, Intracranial Extension, Rhinosinusitis Chronic, Rhinosinusitis Acute, Fungal Sinusitis, Allergic Fungal Rhinosinusitis
- Keywords
- Rhinosinusitis, complicated sinusitis, complications of sinusitis, Magnetic resonance imaging, Computed tompgraphy, MRI, CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Radiation: Multislice CT scan of the paranasal sinuses., Radiation: MRI examination of the paranasal sinuses |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients diagnosed as sinusitis with clinically suspected complications through history and physical examination (site, onset, character of pain, constitutional symptoms, duration).
Key exclusion criteria (1 listed)
- Patients with absolute or relative contraindications for cross sectional imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multislice CT scan of the paranasal sinuses.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. | Radiation | Participants |
| MRI examination of the paranasal sinusesMRI 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. | Radiation | Participants |
Primary outcome
Number of different Types of possible complications detected by CT and MRI
Time frame: 6 months
To diagnose the diagnostic accuracy of CT and MRI in detection of different types of orbital and intracranial complications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 27456592Carr TF. Complications of sinusitis. Am J Rhinol Allergy. 2016 Jul;30(4):241-5. doi: 10.2500/ajra.2016.30.4322.
- Background: PubMed 26307941Marchiano 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.
- Background: PubMed 22764607Fokkens 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.
- Background: PubMed 21939544Chen 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.
- Background: PubMed 19544383Chakrabarti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Th Solyman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multislice CT scan of the paranasal sinuses. and MRI examination of the paranasal sinuses in people with Rhinosinusitis and Intracranial Extension, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed O Khalil, resident (+201001272453, mohamedkhalil@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of different Types of possible complications detected by CT and MRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836935, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.