Fast Magnetic Resonance Imaging as Compared to Computed Tomography Scan in Pediatric Orbital Cellulitis Imaging
Primary Purpose
Orbital Cellulitis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Computed Tomography Scan
Fast Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Orbital Cellulitis
Eligibility Criteria
Inclusion Criteria:
- Children with orbital cellulitis with indications for imaging
Exclusion Criteria:
- All others
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Computed Tomography Scan
Fast Magnetic Resonance Imaging
Arm Description
To determine the presence of periosteal or orbital abscess, intracranial abscess and dural venous sinus thrombosis that are imaged properly with Computed Tomography scan.
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.
Outcomes
Primary Outcome Measures
MRI sensitivity for the detection of orbital cellulitis compared to CT
MRI results will be compared to CT results
Secondary Outcome Measures
Full Information
NCT ID
NCT02711436
First Posted
March 14, 2016
Last Updated
March 14, 2016
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02711436
Brief Title
Fast Magnetic Resonance Imaging as Compared to Computed Tomography Scan in Pediatric Orbital Cellulitis Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Cellulitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computed Tomography Scan
Arm Type
Active Comparator
Arm Description
To determine the presence of periosteal or orbital abscess, intracranial abscess and dural venous sinus thrombosis that are imaged properly with Computed Tomography scan.
Arm Title
Fast Magnetic Resonance Imaging
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Computed Tomography Scan
Intervention Type
Device
Intervention Name(s)
Fast Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
MRI sensitivity for the detection of orbital cellulitis compared to CT
Description
MRI results will be compared to CT results
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with orbital cellulitis with indications for imaging
Exclusion Criteria:
All others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Cohen, MD, PhD
Email
dr.yuvalcohen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Cohen, MD, PhD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuval Cohen, MD, PhD
Email
dr.yuvalcohen@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fast Magnetic Resonance Imaging as Compared to Computed Tomography Scan in Pediatric Orbital Cellulitis Imaging
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