RECRUITING

Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy

Quick Facts

Study Start:2020-09-01
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01484678

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 62 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Males with a contraindication to an MR examination
  2. 2. Males with unstable medical problems
  3. 3. Males who are not able to cooperate during testing
  4. 4. Males with a secondary condition that may impact muscle metabolism, muscle function or functional ability (i.e. cerebral palsy, endocrine disorders, mitochondrial disease)
  5. 5. Daytime ventilation
  6. 6. Implantable Cardioverter Defibrillator- (ICD) or pace maker
  7. 7. Healthy boys/men who participate in competitive sports specific training in excess of 8 hours per week

Contacts and Locations

Study Contact

Krista Vandenborne, PhD
CONTACT
352-273-6100
kvandenb@phhp.ufl.edu
Claudia Senesac, PhD
CONTACT
352-273-6453
csenesac@phhp.ufl.edu

Principal Investigator

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

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Florida

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • Duchenne Muscular Dystrophy
  • Becker Muscular Dystrophy
  • Magnetic Resonance Spectroscopy
  • Magnetic Resonance Imaging
  • Muscle

Additional Relevant MeSH Terms

  • Duchenne Muscular Dystrophy
  • Becker Muscular Dystrophy