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CompletedNCT06966739MYOMSOTUpdated May 13, 2025

Multispectral Optoacustic Imaging in Patients With Myositis

An observational study in Myositis, sponsored by University of Giessen. Completed at 1 site in Germany. Open to participants aged 18 Hours and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by University of Giessen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
51
Ages
18 Hours and older
Sex
All
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Study 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), 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.

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.

02

Conditions studied

  • Myositis

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Keywords

  • msot
  • medical treatment
  • myositis
  • functional parameters
03

In context

Myositis

246 studies on the registry are indexed under Myositis; 104 are open to participants now.

This study's enrollment of 51 is below the median of 226 across 74 observational studies indexed under Myositis.

Browse Myositis studies →

Lead sponsor

University of Giessen is the lead sponsor of 95 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Hours and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • contraindications against an optoacoustic examination
  • pregnancy
  • ingestion of photosensitizers within the last 72 hours
  • current phototherapy
  • known photosensitive disorder
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
51 participants (actual)
Patient registry
No

Groups and cohorts

  • Myositis

    Patients with myositis should be included as well as healthy age and sex matched individuals als control group.

    Other: MSOT of musculature

Interventions

  • OtherMSOT of musculature

    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).

06

What researchers measure

Primary outcomes

  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.

    Time frame: From enrollment to the end of examinations six months

Secondary outcomes

  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.

    Time frame: From enrollment to the end of examinations six months

07

Study locations

1 site
  • Justus-Liebig-Universität Gießen
    Giessen, Hesse 35392, Germany
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2025 to primary completion in May 2025, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2025
First posted
May 13, 2025
StartActual
Mar 3, 2025
Primary completionActual
May 6, 2025
CompletionActual
May 7, 2025
Last update
May 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06966739
Lead sponsor
University of Giessen
Responsible party
Sponsor
First posted
May 13, 2025
Start date
Mar 3, 2025
Primary completion
May 6, 2025
Completion
May 7, 2025
Last update
May 13, 2025

Study contacts

Heidrun Krämer-Best, Prof. Dr.
study chair · Uniklinik Giessen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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