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MRI and Biomarkers for Muscular Dystrophy Study

This research study is looking at how magnetic resonance imaging (MRI) and spectroscopy can help us understand and track Duchenne (DMD) and Becker muscular dystrophy (BMD). Researchers want to see if these imaging methods can show how the disease changes over time and if they can be used to measure the success of future treatments. They will compare the muscles of boys and men with DMD to healthy individuals, monitoring disease progression for 5-10 years. The study will also look at how muscle damage and fat measured by MRI relate to daily activities like walking and muscle strength. A small group will also assess the effect of corticosteroid drugs on muscle measurements. You may be able to join if you are a male between 5 and 62 years old with a confirmed diagnosis of DMD.

Study design
This is an observational study with a planned enrollment of 550 male participants. It will compare individuals with Duchenne and Becker muscular dystrophy to healthy individuals.
What's involved
Participants will have their muscles compared to healthy individuals and will be monitored for disease progression over a 5-10 year period. The study will measure intramuscular lipid and muscle T2.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in intramuscular lipid for up to 3-10 years and changes in muscle T2 for up to 3 months. Correlations will be assessed through study completion, an average of 1 year.

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NCT01484678

Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy

Recruiting
Not specifiedAges 5–62Observational
University of Florida
~550 participants
Updated 2025-10-15 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in intramuscular lipid up to 3-10 years
Measured over Change in baseline up to 3-10 years
+2 more outcomes measured

Conditions

Duchenne Muscular Dystrophy
Becker Muscular Dystrophy

Explore related trials

Becker's Muscular DystrophyDuchenne Muscular DystrophyDystrophin

Where it's being run

3 sites across 3 states
Florida1
Oregon1
Pennsylvania1

Study leadership

  • William Rooney, PhD · PRINCIPAL_INVESTIGATOR · Oregan Health and Science University
  • H. Lee Sweeney, PhD · PRINCIPAL_INVESTIGATOR · University of Florida
  • Krista Vandenborne, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Krista Vandenborne, PhD
[email protected]
352-273-6100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Change from baseline in intramuscular lipid up to 3-10 yearsChange in baseline up to 3-10 years

    In BMD and DMD, the from baseline in intramuscular lipid of upper/ lower extremity and trunk/respiratory muscles, as well as composite measures. MR measures of intramuscular lipid will be measured in yearly intervals for a period up to 3-10 years.

  • Change from baseline in muscle T2 up to 3 months in DMDChange in baseline up to 3 months

    In a subgroup of subjects the effect of corticosteroids on muscle T2 will be measured at 3 and 6 months. Muscle T2 is a noninvasive marker of muscle damage/inflammation and will be measured using MR. This substudy requires its own Primary and Secondary Outcome measures.

  • Correlation between MR measures of intramuscular lipid, functional endpoints and histological markers.Through study completion, an average of 1 year

    In both BMD and DMD, the correlation between MR measures and functional endpoints will be determined, as well as the ability of MR measures to predict future change and loss in function.