NCT06438965 MSOT as Non-invasive Biomarker for Diagnosis and Monitoring of Neuromuscular Diseases
| NCT ID | NCT06438965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Eastern Ontario |
| Condition | Neuromuscular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2027-07 |
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 240 participants in total. It began in 2025-02-07 with a primary completion date of 2027-07.
⚠ 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 goal of this study is to learn if Multispectral Optoacoustic Tomographs (MSOT) works to diagnose and follow the course of neuromuscular diseases (NMDs) in children. MSOT scans will be obtained from muscle region to measure hemo/myoglobin, collagen and lipid content/signal and oxygenation in patients with neuromuscular diseases. No additional research activities -other than MSOT - will be done during this study. Existing clinical, laboratory and imaging data from standard-of-care procedures will be correlated with the MSOT data. The expected total duration of the study is approximately 36 months. Repeated measurements will be done to evaluate disease progression and the value of MSOT in NMD.
Eligibility Criteria
Inclusion Criteria: Patients with neuromuscular disease * Children (from birth (infants that are born term) to 18 years of age) participants or consent through authorized guardian * Confirmed or suspected diagnosis of a neuromuscular disease (through molecular genetics, biopsy, clinical examination) Exclusion Criteria: Participants: * Diagnosis is not consistent with a confirmed or suspected neuromuscular disease * Patients with active skin lesions (e.g. infections, trauma) or confirmed genetic disorders (e.g. epidermolysis bullosa) that predisposes to skin lesion * Medically unstable patients * Tattoo on skin overlying the area to be examined * Missing consent form * Exclusion due to safety concerns of the investigator (subject who has any condition, including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study) * Medication leading to increased light sensitivity
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06438965 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Neuromuscular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06438965 currently recruiting?
Yes, NCT06438965 is actively recruiting participants. Contact the research team at hlochmuller@toh.ca for enrollment information.
Where is the NCT06438965 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06438965 clinical trial?
NCT06438965 is sponsored by Children's Hospital of Eastern Ontario. The trial plans to enroll 240 participants.