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

NCT ID: NCT06438965

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-07

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Multispectral Optoacoustic Tomography (MSOT)

Intervention Type 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.

Interventions

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Multispectral 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Eastern Ontario

OTHER

Sponsor Role lead

Responsible Party

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Hanns Lochmuller

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHEO

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Hanns Lochmuller, Dr.

Role: CONTACT

(613) 737-7600

Facility Contacts

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Ozge Aksel Kilicarslan

Role: primary

613-737-7600 ext. 6051

Tamara Burgess

Role: backup

613-737-7600 ext. 4017

Other Identifiers

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MSOT-01

Identifier Type: -

Identifier Source: org_study_id

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