NCT07378553 Multiparametric Ultrafast Ultrasound Biomarkers for Duchenne and Becker Muscular Dystrophies
| NCT ID | NCT07378553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Duchene Muscular Dystrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2029-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-03-03 with a primary completion date of 2029-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to determine the potential of a multiparametric ultrasound approach to non-invasively monitor disease progression and to serve as an objective outcome measure for future clinical trials in Duchenne and Becker Muscular Dystrophies. The investigators will compare the muscles of ambulatory or non-ambulatory boys/men with Duchenne and Becker Dystrophies with muscles of healthy age-matched individuals of the same age and monitor disease progression in those with muscular dystrophies over a 12-month year period. The ultrafast ultrasound technology used in this study allows the simultaneous assessment of muscle structure, mechanics and physiology, including stiffness, anisotropy, viscosity, intramuscular fat, muscle volume, and microvascular perfusion. The amount of muscle alteration measured will be related to performance in daily activities, such as walking and muscle strength, in order to identify sensitive and objective markers of disease progression.
Eligibility Criteria
Inclusion Criteria: * Inclusion Criteria for patients with Duchenne Muscular Dystrophy: Ambulatory and non-ambulatory males (ages 5-30 at baseline testing) previously diagnosed with Duchenne Muscular Dystrophy based on absence of dystrophin expression. * Inclusion Criteria for patients with Becker Muscular Dystrophy: Ambulatory and non-ambulatory males (ages 5-60 at baseline testing) previously diagnosed with Becker Muscular Dystrophy based on genetically confirmed, reduced or dysfunctional dystrophin. * Inclusion Criteria for Aged-matched controls: Ambulatory males (ages 5-60 years) without disease or injury to the lower and/or upper extremities Exclusion Criteria: * Exclusion Criteria for patients with Duchenne and Becker Muscular Dystrophies: Inability to undergo static exam, missing measurement site (resection/amputation), neurocognitive impairment preventing informed consent * Exclusion Criteria for Age-matched controls: Any condition affecting muscle metabolism/function, neuromuscular disease, or injury to the lower and/or upper extremities in the past 5 years
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07378553 clinical trial?
This trial is open to male participants only, aged 5 Years or older, up to 60 Years, studying Duchene Muscular Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07378553 currently recruiting?
Yes, NCT07378553 is actively recruiting participants. Contact the research team at yann.pereon@chu-nantes.fr for enrollment information.
Where is the NCT07378553 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT07378553 clinical trial?
NCT07378553 is sponsored by Nantes University Hospital. The trial plans to enroll 60 participants.