Quantitative MR Imaging of skeletal muscle in Duchenne and Becker muscular dystrophy

Quantitative MR Imaging of skeletal muscle in Duchenne and Becker muscular dystrophy - Quantitative MRI in DMD and BMD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47455

Enrollment

Registered

2013-02-04

Start date

2013-07-30

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne muscular dystrophy

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The key aspect of our project is that we will apply the same MRI measurement techniques in both DMD and BMD patients, in order to develop an MRI outcome parameter that can be used to assess therapy efficacy in clinical trials. We have the following objectives: 1. to assess the reproducibility of quantitative MRI measurements representing muscle volume, fatty infiltration, edema, fiber architecture and metabolism in diseased muscle 2. to compare the result of these quantitative MRI measurements cross-sectionally between DMD and BMD patients and healthy controls 3. to relate the MRI parameters of the three groups to muscle strength and function 4. to study the usefulness of quantitative MRI in monitoring disease progression by repeating the measurements after 12 months	—

Measure

Time frame

The key aspect of our project is that we will apply the same MRI measurement techniques in both DMD and BMD patients, in order to develop an MRI outcome parameter that can be used to assess therapy efficacy in clinical trials. We have the following objectives: 1. to assess the reproducibility of quantitative MRI measurements representing muscle volume, fatty infiltration, edema, fiber architecture and metabolism in diseased muscle 2. to compare the result of these quantitative MRI measurements cross-sectionally between DMD and BMD patients and healthy controls 3. to relate the MRI parameters of the three groups to muscle strength and function 4. to study the usefulness of quantitative MRI in monitoring disease progression by repeating the measurements after 12 months

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Secondary

Measure	Time frame
nvt.	—

Countries

Netherlands

Outcome results