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Patient accrual is slow and software renewal is costly and beyond our allocated fund for this study.
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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.
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?
To what extent can total exam times be reduced?
Is the software user friendly and would investigators use it?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | <1 month of age SyMRI software used for brain imaging and radiological interpretation |
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| Infants | 1mth - 2 years of age SyMRI software used for brain imaging and radiological interpretation |
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| Adolescents | 2 - 12 years of age SyMRI software used for brain imaging and radiological interpretation |
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| Teenagers | 13-18 years of age SyMRI software used for brain imaging and radiological interpretation |
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| Healthy Adults | Preliminary Evaluation SyMRI software used for brain imaging and radiological interpretation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyMRI Software | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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i) 25 neonates (<1 month of age) ii) 25 infants (1mth - 2 years of age) iii) 25 adolescents (2 - 12 years of age) iv) 25 teenagers (13-18 years of age)
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| Name | Affiliation | Role |
|---|---|---|
| Manohar Shroff, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2017 | Dec 7, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2017 | Dec 7, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |