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

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

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
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.
Device: Computed Tomography Scan
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.
Device: Fast Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI sensitivity for the detection of orbital cellulitis compared to CT
Time Frame: One year
MRI results will be compared to CT results
One year

Collaborators and Investigators

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

Sponsor

Hillel Yaffe Medical Center

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.

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