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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

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.

Condition or disease Intervention/treatment
Brain Injuries Brain Development Abnormality Brain Pathology 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?

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reducing Scan Times and Improving Care Through Quantitative Imaging: Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494855


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Manohar Shroff, MD The Hospital for Sick Children
  Study Documents (Full-Text)

Documents provided by Manohar Shroff, The Hospital for Sick Children:
Study Protocol  [PDF] March 22, 2017
Statistical Analysis Plan  [PDF] March 22, 2017

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Responsible Party: Manohar Shroff, Chief Radiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03494855    
Other Study ID Numbers: 1000048815
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries