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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494855
Recruitment Status : Terminated (Patient accrual is slow and software renewal is costly and beyond our allocated fund for this study.)
First Posted : April 11, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Manohar Shroff, The Hospital for Sick Children

Tracking Information
First Submitted Date January 17, 2018
First Posted Date April 11, 2018
Last Update Posted Date July 16, 2019
Actual Study Start Date June 1, 2016
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2018)
Diagnostic Quality relative to conventional imaging [ Time Frame: Through study completion, an average of 1 year ]
Radiologist compares qualitative diagnostic quality of SyMRI imaging against Conventional Imaging. Measure - Poorer, Equal, Better
Original Primary Outcome Measures
 (submitted: April 6, 2018)
Diagnostic Quality relative to conventional imaging [ Time Frame: Ongoing, until study completion, estimated 1 year ]
Radiologist compares qualitative diagnostic quality of SyMRI imaging against Conventional Imaging. Measure - Poorer, Equal, Better
Change History
Current Secondary Outcome Measures
 (submitted: May 3, 2018)
Scan time for SyMRI vs Conventional MR [ Time Frame: Through study completion, an average of 1 year ]
Compare acquisition time for SyMRI scans vs Conventional MR Measure - Minutes:Seconds
Original Secondary Outcome Measures
 (submitted: April 6, 2018)
Scan time for SyMRI vs Conventional MR [ Time Frame: Ongoing, until study completion, estimated 1 year ]
Compare acquisition time for SyMRI scans vs Conventional MR Measure - Minutes:Seconds
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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?
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)

Condition
  • Brain Injuries
  • Brain Development Abnormality
  • 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.
Study Groups/Cohorts
  • Neonates
    <1 month of age SyMRI software used for brain imaging and radiological interpretation
    Intervention: Device: SyMRI Software
  • Infants
    1mth - 2 years of age SyMRI software used for brain imaging and radiological interpretation
    Intervention: Device: SyMRI Software
  • Adolescents
    2 - 12 years of age SyMRI software used for brain imaging and radiological interpretation
    Intervention: Device: SyMRI Software
  • Teenagers
    13-18 years of age SyMRI software used for brain imaging and radiological interpretation
    Intervention: Device: SyMRI Software
  • Healthy Adults
    Preliminary Evaluation SyMRI software used for brain imaging and radiological interpretation
    Intervention: Device: SyMRI Software
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 12, 2019)
5
Original Estimated Enrollment
 (submitted: April 6, 2018)
106
Actual Study Completion Date January 1, 2019
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03494855
Other Study ID Numbers 1000048815
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Manohar Shroff, The Hospital for Sick Children
Study Sponsor The Hospital for Sick Children
Collaborators Not Provided
Investigators
Principal Investigator: Manohar Shroff, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date July 2019