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Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy

NCT01484678 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2025-10-15

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Shriners Hospitals for Children

    collaborator OTHER

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • William Rooney, PhD · Oregan Health and Science University

  • H. Lee Sweeney, PhD · University of Florida

  • Krista Vandenborne, PhD · University of Florida

Eligibility

Min Age
5 Years
Max Age
62 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01484678 on ClinicalTrials.gov