New Biomarkers in Facioscapulohumeral Muscular Dystrophy, Multispectral Optoacoustic Tomography.
MSOT-FSHD
1 other identifier
interventional
20
1 country
1
Brief Summary
Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most frequent muscular dystrophies in the adulthood. Multi-spectral optoacoustic tomography (MSOT) is an innovative imaging technique able to non-invasively characterize the molecular composition of the muscle tissue. With this pilot study we will explore the performance of MSOT imaging in FSHD patients and correlate the findings with clinical and MRI data, with the final aim to identify new disease biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJuly 6, 2023
April 1, 2023
3 months
April 27, 2023
July 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Optoacoustic Absorption Spectrum (peaks at different wavelengths in arbitrary units) in FSHD muscles
Definition of the Optoacoustic Absorption Spectrum (glycogen, lipid, collagen, hemo/myoglobin peaks at different wavelengths in arbitrary units) of muscles of FSHD patients and evaluation of the differences compared to healthy volunteers.
6 months
Secondary Outcomes (6)
Medical Research Council (MRC) Muscle Strength Grades
6 months
Disease severity (Clinical Severity Scale CSS)
6 months
Phenotyping (FSHD Comprehensive Clinical Evaluation Form CCEF)
6 months
Dynamometer test of muscle strength
6 months
Magnetic resonance imaging
6 months
- +1 more secondary outcomes
Study Arms (2)
Patients
OTHERPatients with FSHD
Controls
OTHERHealthy volunteers
Interventions
Imaging of muscles applying Multi-spectral optoacoustic tomography (MSOT)
Eligibility Criteria
You may qualify if:
- molecular diagnosis of FSHD
- recent pelvic and lower-limb muscle MRI
You may not qualify if:
- presence of conditions that can alter the signal of the muscles under investigation: eg. tattoos, scars or skin abrasions at the site of probe evaluation, recent trauma, decompensated diabetes, symptomatic radiculopathies, acute or chronic inflammatory diseases
- current or presumed pregnancy
- inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Gemelli IRCCS
Rome, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
June 15, 2023
Study Start
June 26, 2023
Primary Completion
September 30, 2023
Study Completion
December 30, 2023
Last Updated
July 6, 2023
Record last verified: 2023-04