Duchenne Muscular DystrophyNCT01633866
Pediatric Radio Frequency Coils Generic
An observational study of Duchenne Muscular Dystrophy and Musculoskeletal Abnormalities, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy, Musculoskeletal Abnormalities
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 participants will be recruited by word-of-mouth, generally from within CCHMC.The healthy participants could include children of faculty or staff members of CCHMC.Because the healthy participants could include children of faculty or staff members, recruitment will be consistent with CCHMC Research Policy.Patients will be recruited at the time of their scheduled clinical scan.We are only using these participants to evaluate the safety and feasibility of the use of the new coils in our patient population.For this reason, we will not focus on the demographics of the participants.However, we will attempt to obtain a broad anatomic size range to match that of the patient population for which the coils were developed.
Who may be able to join
- Healthy participants:
- Male or Female
- Thermally stable
- Any age
- Clinical patients:
- Male or Female
- Thermally stable
- any age
Who cannot join
- Healthy participants \& Clinical patients
- Female participants who are pregnant or lactating
- Subjects iwth standard contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners
The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC).
Read the detailed description
Pediatric Magnetic resonance (MR) imaging techniques have been limited by the unavailability of specialized radio-frequency (RF) coils for pediatric imaging. Typically, MR coils are designed for general purpose adult imaging and lack the mechanical design, flexibility and high channel count needed for pediatric imaging. Furthermore, pediatric patients are often positioned decubitus or prone rather than supine. This makes coil positioning even more challenging and often results in images with low SNR and poor image quality. Many coils used in clinical practice have fixed dimensions that do not fit within the realm of "one-size fits all," especially for the huge variation found in the pediatric patient population.
MRI coil development and optimization is performed by MR manufacturers and in research laboratories across the world including the Imaging Research Center (IRC) of Cincinnati Children's Hospital and Medical Center (CCHMC). Coil development and refinement involves evaluating the new coils on inert phantoms and then imaging examinations performed on healthy participants and patients. The focus of this study protocol is to evaluate the design and performance of investigational coils on patients and healthy participants.
- Keywords
- Magnetic Resonance Imaging
- Medical subject headings
- Muscular Dystrophy, Duchenne, Musculoskeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advances in Radio Frequency for MRI | advances in radio frequency (RF) coil magnetic resonance imaging (MRI) |
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
Measured: Day 1
Secondary outcomes (1)
MRI Image Quality
Measured: 2 Weeks Post MRI Scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Dumoulin, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633866
- Sponsor's protocol ID
- 2012-1041
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2012
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners
- ClinicalTrials.gov ID
- NCT01633866
- Acronym / sponsor ID
- 2012-1041
- Keywords
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 4 Jul 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.
The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC).
Detailed description
Pediatric Magnetic resonance (MR) imaging techniques have been limited by the unavailability of specialized radio-frequency (RF) coils for pediatric imaging. Typically, MR coils are designed for general purpose adult imaging and lack the mechanical design, flexibility and high channel count needed for pediatric imaging. Furthermore, pediatric patients are often positioned decubitus or prone rather than supine. This makes coil positioning even more challenging and often results in images with low SNR and poor image quality. Many coils used in clinical practice have fixed dimensions that do not fit within the realm of "one-size fits all," especially for the huge variation found in the pediatric patient population.
MRI coil development and optimization is performed by MR manufacturers and in research laboratories across the world including the Imaging Research Center (IRC) of Cincinnati Children's Hospital and Medical Center (CCHMC). Coil development and refinement involves evaluating the new coils on inert phantoms and then imaging examinations performed on healthy participants and patients. The focus of this study protocol is to evaluate the design and performance of investigational coils on patients and healthy participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advances in Radio Frequency for MRI | – | –advances in radio frequency (RF) coil magnetic resonance imaging (MRI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy participants will be recruited by word-of-mouth, generally from within CCHMC.The healthy participants could include children of faculty or staff members of CCHMC.Because the healthy participants could include children of faculty or staff members, recruitment will be consistent with CCHMC Research Policy.Patients will be recruited at the time of their scheduled clinical scan.We are only using these participants to evaluate the safety and feasibility of the use of the new coils in our patient population.For this reason, we will not focus on the demographics of the participants.However, we will attempt to obtain a broad anatomic size range to match that of the patient population for which the coils were developed.
Key inclusion criteria (8 listed)
- Male or Female
- Thermally stable
- Any age
- Male or Female
- Thermally stable
Key exclusion criteria (3 listed)
- Healthy participants \& Clinical patients
- Female participants who are pregnant or lactating
- Subjects iwth 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.
Primary outcome
Number of participants with adverse events as measured by heating and comfort participant response
Time frame: Day 1
1 secondary outcome
MRI Image Quality
Time frame: 2 Weeks Post MRI Scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
Charles Dumoulin, PhD 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 Duchenne Muscular Dystrophy and Musculoskeletal Abnormalities, 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 12 Jun 2026.