Recruiting

MSOT

Sponsor:

Children's Hospital of Eastern Ontario

Code:

NCT06438965

Conditions

Neuromuscular Diseases

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Multispectral Optoacoustic Tomography (MSOT)

Study Details

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.

Conditions

Neuromuscular Diseases

Study ID

NCT06438965

Start date

Feb 7, 2025

Status verified date

Feb, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Hanns Lochmuller, Dr.

(613) 737-7600hlochmuller@toh.ca

Locations

CHEO

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Ozge Aksel Kilicarslan

613-737-7600oakselkilicarslan@cheo.on.ca

Tamara Burgess

613-737-7600tburgess@cheo.on.ca

Principal Investigator:

Hugh McMillan, MD

More Information

Sponsor

Children's Hospital of Eastern Ontario

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario on 2025-02-12.