Healthy VolunteersNCT01795989
Use of Specially Designed Pediatric MR Coils on Clinical Scanners
An observational study of Healthy Volunteers and Musculoskeletal Complication, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to test the use of new Magnetic Resonance Imaging (MRI) coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil is the part of the MRI system that collects data to make the MR images. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Musculoskeletal Complication
- What is being tested?
- 1.5T MRI Elbow Coil
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2011to 4 Oct 2016
- 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: Healthy volunteers and pediatric patients seen clinically in Radiology for a standard of care musculoskeletal (MSK) exam
Who may be able to join
- Healthy Participants:
- Male or female
- Age: Old enough to participate in an MR study without sedation (typically greater than 5-6 years old)
- Pediatric Patients:
- Male or female
- Sent for elbow MR or superficial/small parts musculoskeletal MR imaging.
- Age: any age
Who cannot join
- Female participants who are pregnant or lactating (verbal pregnancy screens will be given for all females of child bearing potential prior to the MRI).
- Subjects with standard contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Novel Coils for Pediatric Musculoskeletal MRI
The purpose of this research study is to test the use of new Magnetic Resonance Imaging (MRI) coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil is the part of the MRI system that collects data to make the MR images. The investigators have designed, developed, and built two child-sized coils to use when imaging elbows, wrists, knees, and ankles. These new coils will be better suited to fit infants through teenagers rather than the conventional coils used which were created for adults These MRI coils have not been approved by the US Food and Drug Administration (FDA) and are considered investigational devices.
Read the detailed description
The safety and the clinical efficacy/equivalence of two pediatric 1.5T coils will be evaluated/demonstrated in two phases. Patient safety and image quality will be evaluated/demonstrated in Phase One by collecting images on healthy participants using a combination of the existing commercially available coils and the new coils. Clinical efficacy/equivalence will be evaluated/demonstrated in Phase Two by collecting standard MRI exams in pediatric patients. In Phase Two, the imaging data for a given patient will be collected by one of the two following scenarios : 1) the clinically ordered exams will be completed using a combination of the existing commercially available coils and new coil, with the images from each directly compared, or 2) the clinically ordered scans will be collected using one of the new coils and the images compared to historical de-identified MR exam, age and gender matched patient data (which were acquired using the existing commercially available coils). Results of Phase One will be reported to the IRB. Phase Two will not begin until the IRB has reviewed the results of Phase One and approved the commencement of Phase Two.
- Conditions
- Healthy Volunteers, Musculoskeletal Complication
- Being tested
- 1.5T MRI Elbow Coil
- Keywords
- Coil, MRI, safety, efficacy, musculoskeletal imaging, MSK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5T MRI Elbow CoilDevice
Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Research only musculoskeletal (MSK) MRI for healthy volunteers. Receives: Device: 1.5T MRI Elbow Coil | |
| Clinical Efficacy | Clinically indicated musculoskeletal (MSK) MRI with sequences obtained using this pediatric elbow coil. Receives: Device: 1.5T MRI Elbow Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as measured by heating and comfort participant response.
Each participant will be monitored for adverse events during the MRI scan
Measured: Day 1
Secondary outcomes (1)
MRI Image Quality
The following measures will be individually evaluated on 3-point scale: Overall image quality, Image uniformity overall, and Signal to Noise.
Measured: Up to 3 weeks post MRI participant scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study start18 Nov 2011
- Primary completion29 Dec 2014
- Study completion4 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Emery, M.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795989
- Sponsor's protocol ID
- 2011-2154
- Status last verified
- Sep 2020
- First submitted
- 3 Jul 2012
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Coils for Pediatric Musculoskeletal MRI
- ClinicalTrials.gov ID
- NCT01795989
- Acronym / sponsor ID
- 2011-2154
- Conditions
- Healthy Volunteers, Musculoskeletal Complication
- Keywords
- Coil, MRI, safety, efficacy, musculoskeletal imaging, MSK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 18 Nov 2011 (actual)
- Primary completion
- 29 Dec 2014 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 21 Feb 2013 (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.
The purpose of this research study is to test the use of new Magnetic Resonance Imaging (MRI) coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil is the part of the MRI system that collects data to make the MR images. The investigators have designed, developed, and built two child-sized coils to use when imaging elbows, wrists, knees, and ankles. These new coils will be better suited to fit infants through teenagers rather than the conventional coils used which were created for adults These MRI coils have not been approved by the US Food and Drug Administration (FDA) and are considered investigational devices.
Detailed description
The safety and the clinical efficacy/equivalence of two pediatric 1.5T coils will be evaluated/demonstrated in two phases. Patient safety and image quality will be evaluated/demonstrated in Phase One by collecting images on healthy participants using a combination of the existing commercially available coils and the new coils. Clinical efficacy/equivalence will be evaluated/demonstrated in Phase Two by collecting standard MRI exams in pediatric patients. In Phase Two, the imaging data for a given patient will be collected by one of the two following scenarios : 1) the clinically ordered exams will be completed using a combination of the existing commercially available coils and new coil, with the images from each directly compared, or 2) the clinically ordered scans will be collected using one of the new coils and the images compared to historical de-identified MR exam, age and gender matched patient data (which were acquired using the existing commercially available coils). Results of Phase One will be reported to the IRB. Phase Two will not begin until the IRB has reviewed the results of Phase One and approved the commencement of Phase Two.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: 1.5T MRI Elbow CoilResearch only musculoskeletal (MSK) MRI for healthy volunteers. |
| Clinical Efficacy | – | Device: 1.5T MRI Elbow CoilClinically indicated musculoskeletal (MSK) MRI with sequences obtained using this pediatric elbow coil. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers and pediatric patients seen clinically in Radiology for a standard of care musculoskeletal (MSK) exam
Key inclusion criteria (7 listed)
- Male or female
- Age: Old enough to participate in an MR study without sedation (typically greater than 5-6 years old)
- Male or female
- Sent for elbow MR or superficial/small parts musculoskeletal MR imaging.
- Age: any age
Key exclusion criteria (2 listed)
- Female participants who are pregnant or lactating (verbal pregnancy screens will be given for all females of child bearing potential prior to the MRI).
- Subjects with standard contraindications to MRI.
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 |
|---|---|---|
| 1.5T MRI Elbow CoilPediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants. | Device | Clinical Efficacy, Healthy Volunteers |
Primary outcome
Number of participants with adverse events as measured by heating and comfort participant response.
Time frame: Day 1
Each participant will be monitored for adverse events during the MRI scan
1 secondary outcome
MRI Image Quality
Time frame: Up to 3 weeks post MRI participant scan
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 16 Sep 2020.
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Screening Protocol
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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.
Kathleen Emery, M.D. principal investigator
Children's Hospital Medical Center, Cincinnati
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 Healthy Volunteers and Musculoskeletal Complication, run by Children's Hospital Medical Center, Cincinnati 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 7 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 16 Sep 2020. 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.
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?
Number of participants with adverse events as measured by heating and comfort participant response. (time frame: Day 1). 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 Sep 2020.