Actively Recruiting

Age: 5Years - 62Years
MALE
Healthy Volunteers
NCT01484678

Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy

Led by University of Florida · Updated on 2025-10-15

550

Participants Needed

3

Research Sites

312 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

O

Oregon Health and Science University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy

Who Can Participate

Age: 5Years - 62Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males aged 5 to 30 years diagnosed with Duchenne muscular dystrophy based on clinical features, elevated serum creatine kinase, or genetic confirmation
  • Ambulatory or non-ambulatory males with Duchenne muscular dystrophy
  • Ambulatory males aged 18 to 62 years with Becker muscular dystrophy without lower extremity disease or injury
  • Specific recruitment of Becker muscular dystrophy patients with deletion mutations in dystrophin gene exon 45 or 51
  • Ambulatory healthy males aged 18 to 62 years without lower or upper extremity disease or injury as controls
Not Eligible

You will not qualify if you...

  • Males with contraindications to MRI
  • Males with unstable medical conditions
  • Males unable to cooperate during testing
  • Males with secondary conditions affecting muscle metabolism, function, or ability (e.g., cerebral palsy, endocrine disorders, mitochondrial disease)
  • Males requiring daytime ventilation
  • Males with implantable cardioverter defibrillators or pacemakers
  • Healthy males who participate in competitive sports training exceeding 8 hours per week

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

2

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

3

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Active, Not Recruiting

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Research Team

K

Krista Vandenborne, PhD

CONTACT

K

Kelly Rock, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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