Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

NCT03494855 | Terminated

• 1 other identifier: 1000048815
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Brain Development Abnormality; Brain Pathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Scan time for SyMRI vs Conventional MR

  Through study completion, an average of 1 year

Study Arms (5)

Neonates

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

Device: SyMRI Software

Infants

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

Device: SyMRI Software

Adolescents

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

Device: SyMRI Software

Teenagers

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

Device: SyMRI Software

Healthy Adults

Preliminary Evaluation SyMRI software used for brain imaging and radiological interpretation

Device: SyMRI Software

Interventions

SyMRI Software 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; Healthy Adults; Infants; Neonates; Teenagers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Manohar Shroff, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Radiologist

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: April 11, 2018
• Study Start: June 1, 2016
• Primary Completion: August 22, 2018
• Study Completion: January 1, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)