Clinical Indication for Brain MRINCT02596854
Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images
A study testing Neurological MRI in people with Clinical Indication for Brain MRI, run by GE Healthcare at 6 sites in United States.
Trial summary
This study is being conducted for regulatory submission of the GE Healthcare MAGnetic resonance Image Compilation (MAGiC), a point-of-care synthetic MR reconstruction software for GE 1.5T and 3.0T MR scanners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Indication for Brain MRI
- What is being tested?
- Neurological MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2015to Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must:
- Be an adult 18 years of age or older;
- Have clinical indication for MRI of the brain according to the site standard of care;
- If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by a medically qualified investigator or demonstrated non-pregnant by negative urine pregnancy test;
- Be able to hear and understand instructions without assistive devices;
- Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
- Are able and willing to provide written informed consent by signing the informed consent form (ICF).
Who cannot join
- Subjects will be excluded that:
- Were previously enrolled in this evaluation;
- Have metallic/conductive or electrically/magnetically active implants or attached medical devices (except for dental devices/fillings, surgical clips, and surgical staples) that could be unsafe for MRI;
- Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
- Have severe trauma or pre-existing pathology that is expected to interfere with normal conduct of MR 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Advanced Radiology Services, PC/Spectrum Health
Grand Rapids, Michigan, 49525
University of Wisconsin-Madison
Madison, Wisconsin, 53792
The Mount Sinai Hospital
New York, New York, 10029
Cornell University
New York, New York, 10065
Manhattan Diagnostic Radiology (RadNet)
New York, New York, 10065
About this study
This study is being conducted for regulatory submission of the GE Healthcare MAGnetic resonance Image Compilation (MAGiC), a point-of-care synthetic MR reconstruction software for GE 1.5T and 3.0T MR scanners.
Read the detailed description
This study is a prospective, blinded, multi-center multi-reader (MCMR) clinical trial that is statistically powered for non-inferiority of diagnostic image quality of synthetic MR versus conventional MR and collection of supporting radiologic findings and morphology data from radiologists that reflect anticipated clinical usage of synthetic MR technology.
The study consists of three parts:
- Clinical MR acquisition,
- synthetic MR post-processing at a GE facility, and
- blinded image evaluation (BIE) of conventional and synthetic images for each subject.
The study will enroll eligible adult subjects with clinical indications for brain MRI that meet applicable site MR safety criteria and are not pregnant. The study consists of one visit, the subject's MRI scan, without additional follow-up. Results are expected to be representative of expected clinical usage of synthetic MAGiC MR technology in clinical practice.
- Conditions
- Clinical Indication for Brain MRI
- Being tested
- Neurological MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological MRIDevice
Neurological MRI image collection
| Study group | Role | What they receive |
|---|---|---|
| Neurological MRI | Experimental | Images acquired for post processing with synthetic software. This is a crossover design where all subjects receive the same imaging scan, and comparison is done between the raw conventional scan and post-processed images using the research software. Receives: Device: Neurological MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale
Images were read by board-certified radiologists who reviewed each image and assessed it on a 5 Point scale (1=unacceptable, 2=poor image quality, 3=Acceptable, 4=Good, 5=Excellent) based on the quality of the image (eg, signal-to-noise, clarity of anatomic boundaries, and other parameters). The outcome was reported as the mean diagnostic image quality score difference (synthetic - conventional).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionApr 2016
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.
- More trials run by GE HealthcareThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group will be enrolled from the general imaging population using the scanner available at the investigational site (either 1.5T or 3.0T, based on site determination and not specified per protocol). All participants are assigned to a single group.
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596854
- Sponsor's protocol ID
- 114-2015-GES-0056
- Status last verified
- May 2018
- First submitted
- 21 Oct 2015
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images
- ClinicalTrials.gov ID
- NCT02596854
- Acronym / sponsor ID
- 114-2015-GES-0056
- Conditions
- Clinical Indication for Brain MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Posted 6 Nov 2017
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 regulatory submission of the GE Healthcare MAGnetic resonance Image Compilation (MAGiC), a point-of-care synthetic MR reconstruction software for GE 1.5T and 3.0T MR scanners.
Detailed description
This study is a prospective, blinded, multi-center multi-reader (MCMR) clinical trial that is statistically powered for non-inferiority of diagnostic image quality of synthetic MR versus conventional MR and collection of supporting radiologic findings and morphology data from radiologists that reflect anticipated clinical usage of synthetic MR technology.
The study consists of three parts:
- Clinical MR acquisition,
- synthetic MR post-processing at a GE facility, and
- blinded image evaluation (BIE) of conventional and synthetic images for each subject.
The study will enroll eligible adult subjects with clinical indications for brain MRI that meet applicable site MR safety criteria and are not pregnant. The study consists of one visit, the subject's MRI scan, without additional follow-up. Results are expected to be representative of expected clinical usage of synthetic MAGiC MR technology in clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group will be enrolled from the general imaging population using the scanner available at the investigational site (either 1.5T or 3.0T, based on site determination and not specified per protocol). All participants are assigned to a single group.
| Arm | Type | Receives |
|---|---|---|
| Neurological MRI | Experimental | Device: Neurological MRIImages acquired for post processing with synthetic software. This is a crossover design where all subjects receive the same imaging scan, and comparison is done between the raw conventional scan and post-processed images using the research software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be an adult 18 years of age or older;
- Have clinical indication for MRI of the brain according to the site standard of care;
- If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by a medically qualified investigator or demonstrated non-pregnant by negative urine pregnancy test;
- Be able to hear and understand instructions without assistive devices;
- Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
Key exclusion criteria (6 listed)
- Were previously enrolled in this evaluation;
- Have metallic/conductive or electrically/magnetically active implants or attached medical devices (except for dental devices/fillings, surgical clips, and surgical staples) that could be unsafe for MRI;
- Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
- Have severe trauma or pre-existing pathology that is expected to interfere with normal conduct of MR 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.
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 |
|---|---|---|
| Neurological MRINeurological MRI image collection | Device | Neurological MRI |
Primary outcome
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale
Time frame: 1 day
Images were read by board-certified radiologists who reviewed each image and assessed it on a 5 Point scale (1=unacceptable, 2=poor image quality, 3=Acceptable, 4=Good, 5=Excellent) based on the quality of the image (eg, signal-to-noise, clarity of anatomic boundaries, and other parameters). The outcome was reported as the mean diagnostic image quality score difference (synthetic - conventional).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurological MRI in people with Clinical Indication for Brain MRI, run by GE Healthcare 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 7 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 18 Jun 2018. 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 6 Nov 2017). 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?
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale (time frame: 1 day). 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 18 Jun 2018.