NCT01484678Recruiting
Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
Source: ClinicalTrials.gov · Last updated 15 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this research study is to determine the potential of magnetic resonance imaging, spectroscopy, and whole body imaging to monitor disease progression and to serve as an objective outcome measure for clinical trials in Muscular Dystrophy (MD). The investigators will compare the muscles of ambulatory or non-ambulatory boys/men with DMD with muscles of healthy individuals of the same age and monitor disease progression in those with DMD over a 5-10 year period. The amount of muscle damage and fat that the investigators measure will also be related to performance in daily activities, such as walking and the loss of muscle strength. In a small group of subjects the investigators will also assess the effect of corticosteroid drugs on the muscle measurements. Additionally, the investigators will map the progression of Becker MD following adults with this rare disease. The primary objective is to conduct a multi-centered study to validate the potential of non-invasive magnetic resonance imaging and magnetic resonance spectroscopy to monitor disease progression and to serve as a noninvasive surrogate outcome measure for clinical trials in DMD and BMD. The secondary objective is to characterize the progressive involvement of the lower extremity, upper extremity, trunk/respiratory muscles in boys/men with DMD and BMD guiding clinical trials.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 550 (estimated)
- First submitted
- 10 Oct 2011
- Start date
- 1 Sept 2020
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- University of Florida
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT01484678
What you commit to
- Study type: Observational
- Planned participants: 550
- From 1 Sept 2020 to the primary completion date, 31 Aug 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Males with a secondary condition that may impact muscle metabolism, muscle function or functional ability (i.e. cerebral palsy, endocrine disorders, mitochondrial disease)
Other
- Males with a contraindication to an MR examination
- Males with unstable medical problems
- Males who are not able to cooperate during testing
- Daytime ventilation
- Implantable Cardioverter Defibrillator- (ICD) or pace maker
- Healthy boys/men who participate in competitive sports specific training in excess of 8 hours per week
Who the study is looking for
- 1\. Ambulatory and non-ambulatory males (ages 5-30 at baseline testing) previously diagnosed with DMD based on:
- clinical features with onset of symptoms before age five
- elevated serum creatine kinase level or
- absence of dystrophin expression, as determined by immunostain or western blot (\<2%) and/or DNA confirmation of a dystrophin mutation \*Subjects will not be excluded based on corticosteroid treatment or other clinical trials
- Ambulatory males (ages 18-62) without disease or injury to the lower extremities
- Specific recruitment of a subset of individuals with deletion mutations in the dystrophin gene involving either exon 51 or exon 45.
- 1\. Ambulatory males (ages 18-62) without disease or injury to the lower and/or upper extremities will be eligible to participate in this study
Age in the registry: 5 years to 62 years · Sex: Male · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Active, not recruiting |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.