Clinical Indication for Brain MRINCT05425927
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
A study testing SyMRI 15 (3D) in people with Clinical Indication for Brain MRI and Healthy Volunteers, run by SyntheticMR at 6 sites in United States.
Trial summary
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging, Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Indication for Brain MRI, Healthy Volunteers
- What is being tested?
- SyMRI 15 (3D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Jun 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any gender, aged 0-99 years
- Subject scheduled for MRI of the brain OR Healthy control with passed screening form
- Subject suitable for MRI as judged by investigator
- Subject agrees to 5-20 min extra MRI scan time
- Subject able to understand written and verbal information in English or Spanish
- Provision of informed consent (and assent if applicable)
Who cannot join
- Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site
- Have severe trauma, disability or pre-existing pathology that is expected to interfere with normal conduct of MRI scanning or complete scanning of the brain
- Have medical condition(s) such as those requiring urgent medical care that, in the opinion of a physician investigator, would prevent safe participation in the study
- Adult subjects (aged 18-99 years) in need of anesthesia during MRI scanning
- Pregnancy at time of enrollment determined according to the clinic's MR Safety Screening policy
- Previous enrollment in this investigation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
SimonMed imaging Streeterville
Chicago, Illinois, 606117110
ProScan Imaging
Naples, Florida, 34110
Dent Neurosciences Research Center
New York, New York, 14226
Nemours Children's Health, Nemours Children's Hospital, Florida
Orlando, Florida, 32827
Phoenix Children's hospital
Phoenix, Arizona, 85016
Diagnostic Imaging Sciences Center (DISC) University of Washington Medical Center (UWMC)
Seattle, Washington, 98195
About this study
Official title: Validation of 3D Synthetic MRI for Neuroimaging - Prospective, Multicenter, Multireader Investigation
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
Read the detailed description
This study is a prospective, blinded, multi-center, multi-reader clinical study that is statistically powered for demonstrating non-inferiority of synthetic 3D MR images compared to conventional MR images with respect to sensitivity and specificity of pathological findings.
The study consists of three parts:
- Clinical MR acquisition,
- Synthetic MR post-processing
- Blinded image evaluation of conventional and synthetic images for each subject.
The study will enroll eligible subjects with an already scheduled brain MRI and also healthy volunteers, that meet applicable site MR safety criteria. The routine MRI scan will include approximately 5-20 minutes extra time for the additional images to be taken. This time will be added to the length of the scheduled scan. It is only the time in the MRI scanner that will differ from standard procedures, no other examinations will be performed.
The study consists of one visit, without additional follow-up.
- Being tested
- SyMRI 15 (3D)
- Keywords
- neuroimaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyMRI 15 (3D)Device
Neurological MRI image collection
| Study group | Role | What they receive |
|---|---|---|
| Neurologic Synthetic and Conventional MRI | Experimental | MR images of the brain acquired for post-processing with software (SyMRI 15, 3D).
Comparison is done between the conventional MR images and the post-processed synthetic MR images Receives: Device: SyMRI 15 (3D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Pathological Findings (Full Analysis Set)
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Specificity of Pathological Findings (Full Analysis Set)
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Secondary outcomes (7)
Classification of Pathological Findings
Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Sensitivity (Adult Population)
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings) for synthetic and conventional MR images in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Selectivity (Adult Population)
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding) for synthetic and conventional MR images on the in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Classification of Pathological Findings (Adult Population)
Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Sensitivity (Pediatric Population)
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings) for synthetic and conventional MR images in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Selectivity (Pediatric Population)
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding) for synthetic and conventional MR images on the in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Classification of Pathological Findings (Pediatric Population)
Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Measured: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start27 Jun 2022
- Primary completion10 Feb 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clinical Indication for Brain MRIStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be enrolled from the general imaging population scheduled for an MRI of the brain and healthy volunteers, using the scanner available at the investigational sites. A conventional MRI scan of the brain is taken, and an additional sequence that is processed into synthetic MR images. The conventional and the synthetic MR images from the same subject is compared.
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- SyntheticMR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey H Miller, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425927
- Sponsor's protocol ID
- CIP-003
- Status last verified
- Apr 2025
- First submitted
- 15 Jun 2022
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of 3D Synthetic MRI for Neuroimaging - Prospective, Multicenter, Multireader Investigation
- ClinicalTrials.gov ID
- NCT05425927
- Acronym / sponsor ID
- CIP-003
- Keywords
- neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- SyntheticMRIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
Detailed description
This study is a prospective, blinded, multi-center, multi-reader clinical study that is statistically powered for demonstrating non-inferiority of synthetic 3D MR images compared to conventional MR images with respect to sensitivity and specificity of pathological findings.
The study consists of three parts:
- Clinical MR acquisition,
- Synthetic MR post-processing
- Blinded image evaluation of conventional and synthetic images for each subject.
The study will enroll eligible subjects with an already scheduled brain MRI and also healthy volunteers, that meet applicable site MR safety criteria. The routine MRI scan will include approximately 5-20 minutes extra time for the additional images to be taken. This time will be added to the length of the scheduled scan. It is only the time in the MRI scanner that will differ from standard procedures, no other examinations will be performed.
The study consists of one visit, without additional follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be enrolled from the general imaging population scheduled for an MRI of the brain and healthy volunteers, using the scanner available at the investigational sites. A conventional MRI scan of the brain is taken, and an additional sequence that is processed into synthetic MR images. The conventional and the synthetic MR images from the same subject is compared.
| Arm | Type | Receives |
|---|---|---|
| Neurologic Synthetic and Conventional MRI | Experimental | Device: SyMRI 15 (3D)MR images of the brain acquired for post-processing with software (SyMRI 15, 3D). Comparison is done between the conventional MR images and the post-processed synthetic MR images |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Any gender, aged 0-99 years
- Subject scheduled for MRI of the brain OR Healthy control with passed screening form
- Subject suitable for MRI as judged by investigator
- Subject agrees to 5-20 min extra MRI scan time
- Subject able to understand written and verbal information in English or Spanish
Key exclusion criteria (6 listed)
- Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site
- Have severe trauma, disability or pre-existing pathology that is expected to interfere with normal conduct of MRI scanning or complete scanning of the brain
- Have medical condition(s) such as those requiring urgent medical care that, in the opinion of a physician investigator, would prevent safe participation in the study
- Adult subjects (aged 18-99 years) in need of anesthesia during MRI scanning
- Pregnancy at time of enrollment determined according to the clinic's MR Safety Screening policy
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 15 (3D)Neurological MRI image collection | Device | Neurologic Synthetic and Conventional MRI |
Primary outcome
Sensitivity of Pathological Findings (Full Analysis Set)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Specificity of Pathological Findings (Full Analysis Set)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
7 secondary outcomes
Classification of Pathological Findings
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Sensitivity (Adult Population)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Selectivity (Adult Population)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Classification of Pathological Findings (Adult Population)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Sensitivity (Pediatric Population)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Selectivity (Pediatric Population)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Classification of Pathological Findings (Pediatric Population)
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Jeffrey H Miller, MD principal investigator
Phoenix Children's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SyMRI 15 (3D) in people with Clinical Indication for Brain MRI and Healthy Volunteers, run by SyntheticMR at 6 sites in United States.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity of Pathological Findings (Full Analysis Set) (time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8). The study lists 2 primary outcomes in all. 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 23 Apr 2025.