Quantitative MR Imaging of skeletal muscle in Duchenne and Becker muscular dystrophy
Completed
- Conditions
- Duchenne muscular dystrophy10028302
- Registration Number
- NL-OMON47455
- Lead Sponsor
- Radiologie
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
DMD and BMD patients of 5 years and older with typical muscle weakness and a known genetic mutation in the dystrophin gene.
Healthy age-matched males of 5 years or older form the control group.
Exclusion Criteria
General exclusion criteria are:
- Claustrophobia
- Pacemakers and defibrillators
- Nerve stimulators
- Intracranial clips
- Intraorbital or intraocular metallic fragments
- Cochlear implants
- Ferromagnetic implants (e.g. thoracic implant for scoliosis)
- Inability to lie supine during less than 60 minutes;Exclusion criteria for healthy controls
- any muscle disease
- recent muscle trauma
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The key aspect of our project is that we will apply the same MRI measurement<br /><br>techniques in both DMD and BMD patients, in order to develop an MRI outcome<br /><br>parameter that can be used to assess therapy efficacy in clinical trials.<br /><br>We have the following objectives:<br /><br>1. to assess the reproducibility of quantitative MRI measurements representing<br /><br>muscle volume, fatty infiltration, edema, fiber architecture and metabolism in<br /><br>diseased muscle<br /><br>2. to compare the result of these quantitative MRI measurements<br /><br>cross-sectionally between DMD and BMD patients and healthy controls<br /><br>3. to relate the MRI parameters of the three groups to muscle strength and<br /><br>function<br /><br>4. to study the usefulness of quantitative MRI in monitoring disease<br /><br>progression by repeating the measurements after 12 months</p><br>
- Secondary Outcome Measures
Name Time Method <p>nvt.</p><br>