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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Comparison of the quantitative proportion of collagen, lipid, and hemo/myoglobin signal [Срок оценки: 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]

Вторичные конечные точки (12)

• Comparison of the quantitative amount of lipid and collagen signal [Срок оценки: 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 [Срок оценки: 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 oxygenated/deoxygenated hemo/myoglobin signal [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• CHEO — Ottawa

Идентификаторы

NCT: NCT06438965 · MSOT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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