Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations (SyMRI)

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

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.

Study Overview

• Status: Terminated
• Conditions: Brain Injuries; Brain Pathology; Brain Development Abnormality
• Intervention / Treatment: Device: SyMRI 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 Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Manohar Shroff, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): August 22, 2018
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (ACTUAL): April 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 1000048815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No