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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
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Orbital Cellulitis

Eligibility Criteria

6 Months - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 14, 2016
Last Updated
March 14, 2016
Sponsor
Hillel Yaffe Medical Center
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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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