Multiple MRI Exams, IncludingPhase 1NCT01598766
General Investigative MRI Protocol
A Phase 1 study testing 16 Channel SPEEDER Flex Coil in people with Multiple MRI Exams, Including and Cardiac, run by Toshiba America Medical Systems, Inc. at 1 site in United States.
Trial summary
This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software… Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple MRI Exams, Including, Cardiac, Abdominal
- What is being tested?
- 16 Channel SPEEDER Flex Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2020
- Phase
- Phase 1
- 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 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil.
Who cannot join
- Any contraindication to MRI procedures
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Steinberg Diagnostic Medical Imaging
Henderson, Nevada, 89052
Erin Kelly, PhD, 714-604-6242, ekelly@tams.com
Mark L Winkler, MD
About this study
Official title: General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T
This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.
- Being tested
- 16 Channel SPEEDER Flex Coil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 Channel SPEEDER Flex CoilDevice
This is a 16 element MRI coil, flexible, lightweight. Multiple uses.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Coil | Experimental | This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams Receives: Device: 16 Channel SPEEDER Flex Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
16 Channel Flex Coil
The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.
Measured: May 2012-May 2013
Secondary outcomes (1)
8 Channel Value Breast Coil
clinical evaluation to determine if an 8 channel mri breast coil meets industry standards.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MRI Exams, IncludingStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toshiba America Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark L Winkler, MD, Principal investigator, Steinberg Diagnostic Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598766
- Sponsor's protocol ID
- 05069
- Status last verified
- Feb 2013
- First submitted
- 11 May 2012
- Last updated
- 5 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T
- ClinicalTrials.gov ID
- NCT01598766
- Acronym / sponsor ID
- 05069
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Toshiba America Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 15 May 2012 (estimated)
- 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.
This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Coil | Experimental | Device: 16 Channel SPEEDER Flex CoilThis coil is a lightweight, flexible coil which can be used for many pediatric MRI exams |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil.
Key exclusion criteria (1 listed)
- Any contraindication to MRI procedures
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 |
|---|---|---|
| 16 Channel SPEEDER Flex CoilThis is a 16 element MRI coil, flexible, lightweight. Multiple uses. | Device | Diagnostic Coil |
Primary outcome
16 Channel Flex Coil
Time frame: May 2012-May 2013
The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.
1 secondary outcome
8 Channel Value Breast Coil
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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.
Mark L Winkler, MD principal investigator
Steinberg Diagnostic Medical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 16 Channel SPEEDER Flex Coil in people with Multiple MRI Exams, Including and Cardiac, run by Toshiba America Medical Systems, Inc. at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2013. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Kelly (7146046242, ekelly@tams.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16 Channel Flex Coil (time frame: May 2012-May 2013). 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 5 Feb 2013.