Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT01484678
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
5 Years - 62 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Sep 1, 2020
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: Age Matched Controls
    Age matched non-affected (non-DMD) boys \* This arm is full Age matched non-affected men, matched for men with Becker MD \*Recruiting
  • Arm: Boys/Men with DMD
    This group will include ambulatory and non-ambulatory boys/men with Duchenne Muscular Dystrophy ranging from 5-30 years old. \*Recruiting
  • Arm: Adults with Becker MD
    This group will include ambulatory and non-ambulatory men with Becker Muscular Dystrophy ranging from 18-62 years old. \* Recruiting

Primary Outcome Measure

Change from baseline in intramuscular lipid up to 3-10 years [ Time Frame: Change in baseline up to 3-10 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Krista Vandenborne, PhD
[email protected]
352-273-6100
Kelly Rock, PhD
[email protected]
352-294-5798
Krista Vandenborne, PhD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
William Rooney, PhD
[email protected]
503-418-1532
Olivia Huerta
[email protected]
971-347-6084
Bill Rooney, PhD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Gainesville, FL

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
University of Florida· Gainesville, FLOregon Health and Science University· Portland, ORChildren's Hospital of Philadelphia· Philadelphia, PA

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