Clinical trial NCT03494855: Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations
Official title: Reducing Scan Times and Improving Care Through Quantitative Imaging: Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Injuries
Brain Development Abnormality
Brain Pathology
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Preliminary evaluation - 6 adult volunteers (\>18 years of age)
2. Clinical Evaluation

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)

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Quality relative to conventional imaging
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Scan time for SyMRI vs Conventional MR
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Manohar Shroff, MD
role: PRINCIPAL_INVESTIGATOR
References: