Role of Imaging in Complications of Sinusitis

April 29, 2023 updated by: Mohamed Osama Mohamed, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohamed Th Solyman, Professor

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
Radiation: 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: MRI examination of the paranasal sinuses
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 29, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-04-02MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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