Brain InjuriesSyMRINCT03494855
Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations
An observational study of Brain Injuries and Brain Development Abnormality, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Brain Development Abnormality, Brain Pathology
- What is being tested?
- SyMRI Software
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2016to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Scan Times and Improving Care Through Quantitative Imaging: Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations
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.
Read the 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?
- Being tested
- SyMRI Software
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyMRI SoftwareDevice
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 group | Role | What they receive |
|---|---|---|
| Neonates | <1 month of age SyMRI software used for brain imaging and radiological interpretation Receives: Device: SyMRI Software | |
| Infants | 1mth - 2 years of age SyMRI software used for brain imaging and radiological interpretation Receives: Device: SyMRI Software | |
| Adolescents | 2 - 12 years of age SyMRI software used for brain imaging and radiological interpretation Receives: Device: SyMRI Software | |
| Teenagers | 13-18 years of age SyMRI software used for brain imaging and radiological interpretation Receives: Device: SyMRI Software | |
| Healthy Adults | Preliminary Evaluation SyMRI software used for brain imaging and radiological interpretation Receives: Device: SyMRI Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Quality relative to conventional imaging
Radiologist compares qualitative diagnostic quality of SyMRI imaging against Conventional Imaging.
Measure - Poorer, Equal, Better
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Scan time for SyMRI vs Conventional MR
Compare acquisition time for SyMRI scans vs Conventional MR Measure - Minutes:Seconds
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Jun 2016
- Primary completion22 Aug 2018
- Study completion1 Jan 2019
Why it stopped: Patient accrual is slow and software renewal is costly and beyond our allocated fund for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manohar Shroff, The Hospital for Sick Children
- Investigators
- Manohar Shroff, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494855
- Sponsor's protocol ID
- 1000048815
- Acronym
- SyMRI
- Status last verified
- Jul 2019
- First submitted
- 17 Jan 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Scan Times and Improving Care Through Quantitative Imaging: Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations
- ClinicalTrials.gov ID
- NCT03494855
- Acronym / sponsor ID
- SyMRI / 1000048815
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient accrual is slow and software renewal is costly and beyond our allocated fund for this study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | Device: SyMRI Software<1 month of age SyMRI software used for brain imaging and radiological interpretation |
| Infants | – | Device: SyMRI Software1mth - 2 years of age SyMRI software used for brain imaging and radiological interpretation |
| Adolescents | – | Device: SyMRI Software2 - 12 years of age SyMRI software used for brain imaging and radiological interpretation |
| Teenagers | – | Device: SyMRI Software13-18 years of age SyMRI software used for brain imaging and radiological interpretation |
| Healthy Adults | – | Device: SyMRI SoftwarePreliminary Evaluation SyMRI software used for brain imaging and radiological interpretation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyMRI SoftwareThe 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. | Device | Adolescents, Healthy Adults, Infants, Neonates, Teenagers |
Primary outcome
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
1 secondary outcome
Scan time for SyMRI vs Conventional MR
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Patient accrual is slow and software renewal is costly and beyond our allocated fund for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manohar Shroff, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Brain Development Abnormality, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient accrual is slow and software renewal is costly and beyond our allocated fund for this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Quality relative to conventional imaging (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.