Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

NCT ID: NCT03494855

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-01-01

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?

Conditions

Brain Injuries; Brain Development Abnormality; Brain Pathology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neonates

\<1 month of age SyMRI software used for brain imaging and radiological interpretation

SyMRI Software

Intervention Type: 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.

Infants

1mth - 2 years of age SyMRI software used for brain imaging and radiological interpretation

SyMRI Software

Intervention Type: 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.

Adolescents

2 - 12 years of age SyMRI software used for brain imaging and radiological interpretation

SyMRI Software

Intervention Type: 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.

Teenagers

13-18 years of age SyMRI software used for brain imaging and radiological interpretation

SyMRI Software

Intervention Type: 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.

Healthy Adults

Preliminary Evaluation SyMRI software used for brain imaging and radiological interpretation

SyMRI Software

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Manohar Shroff

Chief Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manohar Shroff, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1000048815

Identifier Type: -

Identifier Source: org_study_id