Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

Terminated

• Conditions: Brain Development Abnormality; Brain Pathology; Brain Injuries
• Interventions: Device: SyMRI Software

• Registration Number: NCT03494855
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

Synthetic MR Technologies has created a quantified imaging solution - SyMRI - to enable radiologists to acquire quantified images and always obtain the best contrast images. This study represents an attempt to assess the clinical utility of this software.

Detailed Description

Typical magnetic resonance imaging (MRI) involves taking many images called 'contrasts' to look at the body in different ways. Standard scan settings are usually good enough for a radiologist to review. The best settings often change with the age of the patient and their health, and are time consuming to determine. Quantified imaging is an alternative to contrast-based imaging which explicitly measures tissue properties and can be used to create almost any contrast. This method of imaging has been held back by a lack of the right software. Synthetic MR Technologies has created a quantified imaging solution - SyMRI - to enable radiologists to acquire quantified images and always obtain the best contrast images.

The objective of this study is to evaluate SyMRI in a pediatric population to determine if Sickkids would be interested in purchasing this product / support Health Canada approval. Specifically, the investigators are interested in determining if SyMRI is clinically useful:

* Is synthetic imaging quality comparable / better than conventional imaging?

* Qualitative - Are radiologists more confident using synthetic MR vs conventional

* Quantitative - Signal-to-noise (SNR) and Contrast-to-noise (CNR)

* To what extent can total exam times be reduced?

* Is the software user friendly and would investigators use it?

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-11
• Primary Completion: 2018-08-22
• Study Completion: 2019-01-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Any stable patient undergoing clinical MRI of the brain is eligible for this study.
• Research patients undergoing research MRI of the brain for another study will be eligible.

Exclusion Criteria

• Only those patients where an additional 10 minutes of MR imaging would not be advisable (ie. unstable, implants) or possible (due to scheduling constraints) will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Teenagers	SyMRI Software	13-18 years of age SyMRI software used for brain imaging and radiological interpretation
Healthy Adults	SyMRI Software	Preliminary Evaluation SyMRI software used for brain imaging and radiological interpretation
Infants	SyMRI Software	1mth - 2 years of age SyMRI software used for brain imaging and radiological interpretation
Neonates	SyMRI Software	\<1 month of age SyMRI software used for brain imaging and radiological interpretation
Adolescents	SyMRI Software	2 - 12 years of age SyMRI software used for brain imaging and radiological interpretation

Primary Outcome Measures

Name	Time	Method
Diagnostic Quality relative to conventional imaging	Through study completion, an average of 1 year	Radiologist compares qualitative diagnostic quality of SyMRI imaging against Conventional Imaging.; Measure - Poorer, Equal, Better

Secondary Outcome Measures

Name	Time	Method
Scan time for SyMRI vs Conventional MR	Through study completion, an average of 1 year	Compare acquisition time for SyMRI scans vs Conventional MR Measure - Minutes:Seconds

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada