Multispectral Optoacoustic Imaging (MSOT) As Non-invasive Biomarker for Diagnosis and Monitoring of Neuromuscular Diseases (MSOT-NMD)

Children's Hospital of Eastern Ontario1 site in 1 country240 target enrollmentFebruary 7, 2025

ConditionsNeuromuscular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neuromuscular Diseases
Sponsor: Children's Hospital of Eastern Ontario
Enrollment: 240
Locations: 1
Primary Endpoint: Comparison of the quantitative proportion of collagen, lipid, and hemo/myoglobin signal
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 7, 2025

End Date

July 2028

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Children's Hospital of Eastern Ontario

Responsible Party

Principal Investigator

Hanns Lochmuller

Professor of Neurology

Children's Hospital of Eastern Ontario

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

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

Comparison of the quantitative amount of oxygenated/deoxygenated hemo/myoglobin signal(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)
Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin, lipid, and collagen signal determined by MSOT at different positions /muscle groups intraindividually(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)
Correlation of the collagen signal(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)
Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined with MSOT clinical assessments(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)
Correlation of the collagen signal determined with MSOT with patient reported outcome measures.(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)
Comparison of the quantitative amount of lipid and collagen signal(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)
Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin signal(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)
Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with the current treatment regimen(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)
Comparison of the MSOT-determined quantitative amount of hemo/myoglobin, lipid, and collagen signal at different positions /muscle groups intraindividually(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)
Correlation of the collagen signal determined with MSOT with routine laboratory tests(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)
Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with routine laboratory tests(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)
Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with patient reported outcome measures.(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)
Correlation of the collagen signal determined with MSOT with the current treatment regimen(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)