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Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

T

The Hospital for Sick Children

Status

Terminated

Conditions

Brain Injuries
Brain Development Abnormality
Brain Pathology

Treatments

Device: SyMRI Software

Study type

Observational

Funder types

Other

Identifiers

NCT03494855
1000048815

Details and patient eligibility

About

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.

Full 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?

Enrollment

5 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

5 participants in 5 patient groups

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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