Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

Brain Injuries Clinical Trial

— SyMRI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03494855
• Other study ID #: 1000048815
• Status: Terminated
• Start date: June 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: July 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 1, 2019
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Development Abnormality
• Brain Injuries
• Brain Pathology

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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