Diagnostic ImagingNCT02687750
Testing of Radiofrequency Coil for Clinical 19F MRI
A study testing MRI in people with Diagnostic Imaging, run by Western University, Canada.
Trial summary
Testing of a dual tuned proton/fluorine MRI radio frequency coil Images were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers. This trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- Healthy Volunteer
Who cannot join
- MRI incompatible patient
- claustrophobia
About this study
Testing of a dual tuned proton/fluorine MRI radio frequency coil
Images were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers.
This trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949)
- Conditions
- Diagnostic Imaging
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Investigational device is a dual tuned (fluorine/proton) MRI surface coil designed and produced by Clinical MR solutions
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Eppendorf tubes containing 10% fluorine-19 diluted in agar were taped to the upper thigh of participants. Investigational device was used to image the phantom with Magnetic resonance imaging (MRI). Imaging was performed for anatomical (proton) and fluorine (agent detection). Total scan time was under 1 hour.
Objectives:
* Verify RF coil functionality
* Obtain preliminary detection threshold limits using a human coil loading Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify radio frequency coil imaging functionality on humans
Proof of successful MRI signal acquisition with use of investigation device.
Measured: 1 hour of scanning
Measure signal repeatability in different patients
MRI signal strength is expected to vary slightly based on patient weight.
Measured: 1 hour of scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Foster, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687750
- Sponsor's protocol ID
- RRI-PF-001
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Radiofrequency Coil for Clinical 19F MRI
- ClinicalTrials.gov ID
- NCT02687750
- Acronym / sponsor ID
- RRI-PF-001
- Conditions
- Diagnostic Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Feb 2016 (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.
Testing of a dual tuned proton/fluorine MRI radio frequency coil
Images were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers.
This trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Device: MRIEppendorf tubes containing 10% fluorine-19 diluted in agar were taped to the upper thigh of participants. Investigational device was used to image the phantom with Magnetic resonance imaging (MRI). Imaging was performed for anatomical (proton) and fluorine (agent detection). Total scan time was under 1 hour. Objectives: * Verify RF coil functionality * Obtain preliminary detection threshold limits using a human coil loading |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Volunteer
Key exclusion criteria (2 listed)
- MRI incompatible patient
- claustrophobia
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 |
|---|---|---|
| MRIInvestigational device is a dual tuned (fluorine/proton) MRI surface coil designed and produced by Clinical MR solutions | Device | MRI |
Primary outcome
Verify radio frequency coil imaging functionality on humans
Time frame: 1 hour of scanning
Proof of successful MRI signal acquisition with use of investigation device.
Measure signal repeatability in different patients
Time frame: 1 hour of scanning
MRI signal strength is expected to vary slightly based on patient weight.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Diagnostic Imaging, run by Western University, 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 1 inclusion and 2 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Verify radio frequency coil imaging functionality on humans (time frame: 1 hour of scanning). 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 22 Feb 2016.