Fast Magnetic Resonance Imaging as Compared to Computed Tomography Scan in Pediatric Orbital Cellulitis Imaging
March 14, 2016 updated by: Hillel Yaffe Medical Center
The aim of the study is to compare orbital and central nervous system (CNS) imaging with Computed Tomography (CT) scan to that of Fast Magnetic Resonance Imaging (Fast MRI) in children with mild, moderate or severe orbital cellulitis with medical indications for imaging.
Study Overview
Status
Unknown
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 Locations
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Hadera, Israel, 38100
- Hillel Yaffe Medical Center
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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
6 months to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children with orbital cellulitis with indications for imaging
Exclusion Criteria:
- All others
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: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Computed Tomography Scan
To determine the presence of periosteal or orbital abscess, intracranial abscess and dural venous sinus thrombosis that are imaged properly with Computed Tomography scan.
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ACTIVE_COMPARATOR: Fast Magnetic Resonance Imaging
To determine the presence of periosteal or orbital abscess, intracranial abscess and dural venous sinus thrombosis that are imaged properly with T1/T2-weighted MRI.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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MRI sensitivity for the detection of orbital cellulitis compared to CT
Time Frame: One year
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MRI results will be compared to CT results
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuval Cohen, MD, PhD, Hillel Yaffe Medical Center
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
April 1, 2016
Primary Completion (ANTICIPATED)
April 1, 2017
Study Completion (ANTICIPATED)
April 1, 2017
Study Registration Dates
First Submitted
March 14, 2016
First Submitted That Met QC Criteria
March 14, 2016
First Posted (ESTIMATE)
March 17, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
March 17, 2016
Last Update Submitted That Met QC Criteria
March 14, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYMC-0022-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.