Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

Study Overview
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Brief Summary
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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
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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?

Official Title
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Reducing Scan Times and Improving Care Through Quantitative Imaging: Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

Conditions
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Brain Injuries, Brain Development Abnormality, Brain Pathology

Intervention / Treatment
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* Device: SyMRI Software


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates<br><1 month of age SyMRI software used for brain imaging and radiological interpretation | Device: SyMRI Software<br>* The MDME sequence aims to provide whole absolute quantification of T1, T2, PD and B1 inhomogeneity in 5 minutes at typical clinical resolution (0.8 x 0.8 x 5mm). SyMRI software then allows a user to synthesize any almost image contrast (T1, T2, PD, FLAIR, IR, DIR, etc) by adjusting imaging parameters after the fact.<br>|
| Infants<br>1mth - 2 years of age SyMRI software used for brain imaging and radiological interpretation | Device: SyMRI Software<br>* The MDME sequence aims to provide whole absolute quantification of T1, T2, PD and B1 inhomogeneity in 5 minutes at typical clinical resolution (0.8 x 0.8 x 5mm). SyMRI software then allows a user to synthesize any almost image contrast (T1, T2, PD, FLAIR, IR, DIR, etc) by adjusting imaging parameters after the fact.<br>|
| Adolescents<br>2 - 12 years of age SyMRI software used for brain imaging and radiological interpretation | Device: SyMRI Software<br>* The MDME sequence aims to provide whole absolute quantification of T1, T2, PD and B1 inhomogeneity in 5 minutes at typical clinical resolution (0.8 x 0.8 x 5mm). SyMRI software then allows a user to synthesize any almost image contrast (T1, T2, PD, FLAIR, IR, DIR, etc) by adjusting imaging parameters after the fact.<br>|
| Teenagers<br>13-18 years of age SyMRI software used for brain imaging and radiological interpretation | Device: SyMRI Software<br>* The MDME sequence aims to provide whole absolute quantification of T1, T2, PD and B1 inhomogeneity in 5 minutes at typical clinical resolution (0.8 x 0.8 x 5mm). SyMRI software then allows a user to synthesize any almost image contrast (T1, T2, PD, FLAIR, IR, DIR, etc) by adjusting imaging parameters after the fact.<br>|
| Healthy Adults<br>Preliminary Evaluation SyMRI software used for brain imaging and radiological interpretation | Device: SyMRI Software<br>* The MDME sequence aims to provide whole absolute quantification of T1, T2, PD and B1 inhomogeneity in 5 minutes at typical clinical resolution (0.8 x 0.8 x 5mm). SyMRI software then allows a user to synthesize any almost image contrast (T1, T2, PD, FLAIR, IR, DIR, etc) by adjusting imaging parameters after the fact.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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