NCT02711436

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 14, 2016

Last Update Submit

March 14, 2016

Conditions

Orbital Cellulitis

Outcome Measures

Primary Outcomes (1)

  • MRI sensitivity for the detection of orbital cellulitis compared to CT

    MRI results will be compared to CT results

    One year

Study Arms (2)

Computed Tomography Scan

ACTIVE COMPARATOR

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

Fast Magnetic Resonance Imaging

ACTIVE COMPARATOR

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

Interventions

Computed Tomography ScanDEVICE
Computed Tomography Scan
Fast Magnetic Resonance ImagingDEVICE
Fast Magnetic Resonance Imaging

Eligibility Criteria

Age6 Months - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with orbital cellulitis with indications for imaging

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Orbital Cellulitis

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Orbital DiseasesEye DiseasesCellulitisConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Yuval Cohen, MD, PhD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Cohen, MD, PhD

CONTACT

dr.yuvalcohen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

March 17, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)