MSOT as Non-invasive Biomarker for Diagnosis and Monitoring of Neuromuscular Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorChildren's Hospital of Eastern Ontario

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Children with various neuromuscular diseases who are seen at the Children's Hospital of Eastern Ontario will be offered to participate in the study as part of their diagnostic work-up and at regular intervals during their ongoing care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Multispectral Optoacoustic Tomography (MSOT)

    Device

    MSOT scans will be obtained from two muscle region to measure hemo/myoglobin, collagen and lipid content/signal and oxygenation in patient with neuromuscular diseases.

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: Patient with neuromuscular disease1 intervention

Trial outcomes

Primary outcomes

1

Comparison of the quantitative proportion of collagen, lipid, and hemo/myoglobin signal

Comparison of the quantitative proportion of collagen, lipid, and hemo/myoglobin signal determined by MSOT in muscle tissue of patients with different neuromuscular diseases with their clinical data.

Time frame
Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study

Secondary outcomes

1

Comparison of the quantitative amount of lipid and collagen signal

Comparison of the quantitative amount of lipid and collagen signal determined by MSOT in muscle tissue of children with different neuromuscular diseases.

Time frame
Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study
2

Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin signal

Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin signal in muscle tissue of children with different neuromuscular diseases.

Time frame
Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study
3

Comparison of the quantitative amount of oxygenated/deoxygenated hemo/myoglobin signal

Comparison of the quantitative amount of oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT in muscle tissue of children with different neuromuscular diseases

Time frame
Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study
4

Comparison of the MSOT-determined quantitative amount of hemo/myoglobin, lipid, and collagen signal at different positions /muscle groups intraindividually

Comparison of the MSOT-determined quantitative amount of hemo/myoglobin, lipid, and collagen signal at different positions /muscle groups intraindividually in children with different neuromuscular diseases, to identify disease specific distribution patterns

Time frame
Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study

Other outcomes

Sponsors and contacts

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