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MyositisMYOMSOTNCT06966739

Multispectral Optoacustic Imaging in Patients With Myositis

An observational study of Myositis, run by University of Giessen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Myositis syndromes are a relatively rare group of diseases in which acquired inflammation of the muscles occurs. According to clinical, histological and immunopathological criteria, autoimmune (dermatomyositis, polymyositis, immune-mediated necrotizing myopathy, anti-synthetase syndrome, inclusion body myositis)… Read more about this study

Who is it for?
Ages 18 hours and olderHealthy volunteers can take part
Conditions the study is for
Myositis
What is being tested?
MSOT of musculature
How many people
51 participants
Where
1 siteGermany
Study dates
3 Mar 2025to 7 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 hours and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study population consits of patients with myositis and an age and gender matched control group.

Who may be able to join

  • patients with myositis undergoing treatment at the integrated muscle center (imz) of the University Hospital of Gießen

Who cannot join

  • contraindications against an optoacoustic examination
  • pregnancy
  • ingestion of photosensitizers within the last 72 hours
  • current phototherapy
  • known photosensitive disorder

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Justus-Liebig-Universität Gießen

    Giessen, Hesse, 35392

Other trials in Germany

About this study

Myositis syndromes are a relatively rare group of diseases in which acquired inflammation of the muscles occurs. According to clinical, histological and immunopathological criteria, autoimmune (dermatomyositis, polymyositis, immune-mediated necrotizing myopathy, anti-synthetase syndrome, inclusion body myositis), pathogen-related and so-called special forms (e.g. checkpoint-inhibitor-related) of myositis can be distinguished.

A typical symptom of the disease is progressive muscle weakness. In addition, especially a possible extramuscular organ manifestation can lead to increased morbidity.

Read more

The initiation of appropriate drug therapy and regular follow-ups to measure the success of the therapy are of crucial importance. Magnetic Resonance Imaging (MRI) and sonography are imaging methods that have proven effective for this purpose to date.

The former can be used to detect changes such as fatty remodeling, edema or inflammatory changes using T1- and T2-weighted images and Short-Tau-Inversion-Recovery (STIR). However, the duration of the examination, the lack of space and the high costs are certainly a limitation of the examination. Furthermore, patients with corresponding contraindications, such as a pacemaker.

Sonography of the musculature is therefore also important. In particular, changes in the muscle parenchyma in the sense of increasing echogenicity can be detected in this context. Moreover, regional atrophy can also be detected in this modality. However, myosonography is more of a screening procedure for neuromuscular diseases than it is suitable for monitoring progression and therapy.

Another option is the method of multispectral optoacoustic imaging (MSOT), in which ultrasound is combined with optical imaging using laser beams.

Depending on the wavelength, different chromophores such as hemoglobin or melanin (wavelength in the visible range of light) or lipids and proteins (wavelength in the near-infrared range, long-wave light) can be imaged.

Optoacoustic imaging thus provides information about morphological as well as molecular and functional conditions.

The advantages of this imaging have already been established in the context of various neuromuscular diseases:

For example, a significant increase in collagen concentration was shown in patients with Duchenne muscular dystrophy compared to a healthy control group as a possible marker of fibrosis. A significant correlate was also found in the clinical neurological examination. Particularly striking here was an indirect correlation between the 6-minute walk test and the collagen concentration.

The aforementioned imaging can also offer advantages for patients with neuromuscular diseases, particularly with regard to therapy monitoring.

Objective and quantitative measurement of disease progression is essential here. Optoacoustic imaging allows functional and molecular parameters in particular to be differentiated. This enables early and objective quantitative measurement of possible tissue loss, which can ultimately influence further therapy.

The aim of the present study is to carry out functional and molecular imaging using optoacoustic imaging to evaluate possible functional and molecular parameters, which may prove to be suitable markers for monitoring progression.

The aim of the study is to investigate whether the examination technique could be suitable for monitoring the progression of myositis.

All patients with a neuromuscular disease of the NMZ will be included in this trial.

Conditions
Myositis
Being tested
MSOT of musculature
Keywords
msot, medical treatment, myositis, functional parameters
Medical subject headings
Myositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MSOT of musculatureOther

    All measurements using multispectral optoacustic tomography (MSOT) are performed on the paraspinal muscles as well as the trapezius, rectus abdominus and the proximal and distal limb muscles in a right vs. left comparison (leg proximal: quadriceps and ischiocrural muscle, leg distal triceps surae muscle, tibialis anterior muscle; arm proximal: M. biceps, distal: forearm flexors).

Study groups in NCT06966739
Study groupRoleWhat they receive
MyositisPatients with myositis should be included as well as healthy age and sex matched individuals als control group.
Receives: Other: MSOT of musculature

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parchenchmymal changes in the muscles in the context of myositis

    The primary endpoint of the study is the concentration of hemoglobin as correlate for an ongoing inflammation in the muscle compared to a healthy control group. The following hypothesis applies: The concentration of hemoglobin is increased in patients with myositis compared to a healthy control group.

    Measured: From enrollment to the end of examinations six months

Secondary outcomes (1)
  1. Concentration of collagen and lipids in the musculature compared to a healthy control group

    Myositis is known to lead to remodelling processes in the muscles, in the sense of connective tissue or fatty remodelling. Therefore, the secondary outcome parameter is the concentration of collagen in the musculature of patients with myositis compared to a healthy control group. A further secondary outcome measure is the concentration of lipids in the muscles of patients with myositis as a correlate for fatty remodelling.

    It is hypothesised that the concentration of lipids and collagen is increased in patients with myositis compared to a healthy control group.

    Measured: From enrollment to the end of examinations six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start3 Mar 2025
  3. Primary completion6 May 2025
  4. Study completion7 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06966739
Sponsor's protocol ID
MYOMSOT
Acronym
MYOMSOT
Status last verified
May 2025
First submitted
12 Mar 2025
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Myositis, run by University of Giessen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parchenchmymal changes in the muscles in the context of myositis (time frame: From enrollment to the end of examinations six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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