New Biomarkers in Facioscapulohumeral Muscular Dystrophy, Multispectral Optoacoustic Tomography. (MSOT-FSHD)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: FSHD

Treatments: Device: MSOT Acuity Echo

Study type: Interventional

Funder types: Other

Identifiers

NCT05902884

5374

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• molecular diagnosis of FSHD
• recent pelvic and lower-limb muscle MRI

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patients

Other group

Description:

Patients with FSHD

Treatment:

Device: MSOT Acuity Echo

Controls

Other group

Description:

Healthy volunteers

Treatment:

Device: MSOT Acuity Echo