MyositisMYOMSOTNCT06966739
Multispectral Optoacustic Imaging in Patients With Myositis
An observational study of Myositis, run by University of Giessen at 1 site in Germany.
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.
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 group | Role | What they receive |
|---|---|---|
| Myositis | Patients 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.
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)
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.
- First posted13 May 2025
- Study start3 Mar 2025
- Primary completion6 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidrun Krämer-Best, Prof. Dr., Study chair, Uniklinik Giessen
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multispectral Optoacustic Imaging in Patients With Myositis
- ClinicalTrials.gov ID
- NCT06966739
- Acronym / sponsor ID
- MYOMSOT / MYOMSOT
- Conditions
- Myositis
- Keywords
- msot, medical treatment, myositis, functional parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myositis | – | Other: MSOT of musculaturePatients with myositis should be included as well as healthy age and sex matched individuals als control group. |
Who may qualify
- Ages
- 18 hours and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consits of patients with myositis and an age and gender matched control group.
Key inclusion criteria (1 listed)
- patients with myositis undergoing treatment at the integrated muscle center (imz) of the University Hospital of Gießen
Key exclusion criteria (5 listed)
- contraindications against an optoacoustic examination
- pregnancy
- ingestion of photosensitizers within the last 72 hours
- current phototherapy
- known photosensitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSOT of musculatureAll 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). | Other | Myositis |
Primary outcome
Parchenchmymal changes in the muscles in the context of myositis
Time frame: From enrollment to the end of examinations six months
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.
1 secondary outcome
Concentration of collagen and lipids in the musculature compared to a healthy control group
Time frame: From enrollment to the end of examinations six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidrun Krämer-Best, Prof. Dr. study chair
Uniklinik Giessen
1 site in 1 country: see every site and its status.
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.