New Biomarkers in Facioscapulohumeral Muscular Dystrophy, Multispectral Optoacoustic Tomography.

NCT ID: NCT05902884

Last Updated: 2023-07-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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FSHD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients

Patients with FSHD

Group Type OTHER

MSOT Acuity Echo

Intervention Type DEVICE

Imaging of muscles applying Multi-spectral optoacoustic tomography (MSOT)

Controls

Healthy volunteers

Group Type OTHER

MSOT Acuity Echo

Intervention Type DEVICE

Imaging of muscles applying Multi-spectral optoacoustic tomography (MSOT)

Interventions

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MSOT Acuity Echo

Imaging of muscles applying Multi-spectral optoacoustic tomography (MSOT)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mauro Monforte

Role: CONTACT

+390630154155

Facility Contacts

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Mauro Monforte

Role: primary

Other Identifiers

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5374

Identifier Type: -

Identifier Source: org_study_id

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