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RecruitingNCT06438965Updated Feb 12, 2025

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

An observational study in Neuromuscular Diseases, sponsored by Children's Hospital of Eastern Ontario. Recruiting at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Children's Hospital of Eastern Ontario · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
Up to 18 Years
Sex
All
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Study 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.

02

Conditions studied

  • Neuromuscular Diseases
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In context

Neuromuscular Diseases

361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.

This study's planned enrollment of 240 is above the median of 72 across 144 observational studies indexed under Neuromuscular Diseases.

Browse Neuromuscular Diseases studies →

Lead sponsor

Children's Hospital of Eastern Ontario is the lead sponsor of 84 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, , clinical examination)

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient with neuromuscular disease

    Muscle regions of the patients with neuromuscular diseases will be imaged using the MSOT device. Repeated measurements will be done after 6-12 months.

    Device: Multispectral Optoacoustic Tomography (MSOT)

Interventions

  • DeviceMultispectral Optoacoustic Tomography (MSOT)

    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.

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What researchers measure

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

  5. Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin, lipid, and collagen signal determined by MSOT at different positions /muscle groups intraindividually

    Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin, lipid, and collagen signal determined by MSOT 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

  6. Correlation of the collagen signal

    Correlation of the collagen signal determined with MSOT with clinical assessments performed on a routine level during visits.

    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

  7. Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined with MSOT clinical assessments

    Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined with MSOT clinical assessments performed on a routine level during visits.

    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

  8. Correlation of the collagen signal determined with MSOT with routine laboratory tests

    Correlation of the collagen signal determined with MSOT with routine laboratory tests such as blood creatine kinase (CK) levels, transaminases.

    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

  9. Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with routine laboratory tests

    Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with routine laboratory tests such as blood CK levels, transaminases.

    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

  10. Correlation of the collagen signal determined with MSOT with patient reported outcome measures.

    Correlation of the collagen signal determined with MSOT with patient reported outcome measures.

    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

  11. Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with patient reported outcome measures.

    Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with patient reported outcome measures.

    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

  12. Correlation of the collagen signal determined with MSOT with the current treatment regimen

    Correlation of the collagen signal determined with MSOT with the current treatment regimen in patients with NMD.

    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

  13. Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with the current treatment regimen

    Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with the current treatment regimen in patients with NMD.

    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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06438965
Lead sponsor
Children's Hospital of Eastern Ontario
Responsible party
Hanns Lochmuller (Professor of Neurology, Children's Hospital of Eastern Ontario) — Principal investigator
First posted
Jun 3, 2024
Start date
Feb 7, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Feb 12, 2025

Study contacts

Hanns Lochmuller, Dr.
Contact
hlochmuller@toh.ca
(613) 737-7600

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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