Muscular DiseasesMSOT_musclesNCT03979157
Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)
A study testing Multispectral Optoacoustic Tomography in people with Muscular Diseases, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This study aims to determine hemoglobin and collagen levels in muscles before and after exercise, and over time, using Multispectral Optoacoustic Tomography (MSOT). During MSOT, a transducer is placed on the skin similar to a conventional sonography and instead of sound, energy is supplied to the tissue by means of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscular Diseases
- What is being tested?
- Multispectral Optoacoustic Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 14 Oct 2019to 23 Jun 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
Who cannot join
- any reference to a myopathy
- pregnancy
- tattoo in the scanning region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time
This study aims to determine hemoglobin and collagen levels in muscles before and after exercise, and over time, using Multispectral Optoacoustic Tomography (MSOT). During MSOT, a transducer is placed on the skin similar to a conventional sonography and instead of sound, energy is supplied to the tissue by means of light flashes. This leads to a constant change of minimal expansions and contractions (thermoelastic expansion) of individual tissue constituents or molecules. The resulting sound waves can then be detected by the same examination unit.
Read the detailed description
Duchenne muscular dystrophy (DMD) is one of the most common progressive childhood muscle diseases with an incidence of 1 in 3500 male newborns and is associated primarily with decreased life expectancy. Pathogenetically, there is a deficiency of dystrophin, a structural protein of the sarcolemma, which is caused by mutations (usually deletions) of the dystrophin gene (Xp21.3-p21.2). The result of dystrophin deficiency is a necrosis of muscle cells that are replaced by connective tissue and adipose tissue. Clinical scores (6-minute walk test, 6MWT) and MRI studies to characterize the degenerative changes of skeletal muscle in the early stages are available for the quantitative assessment of the disease progression as well as therapy effects, the significance of which is controversially discussed. However, the highly sensitive assessment of gene therapy effects will become increasingly important in the future. Sensitive, non-invasive methods for the detection of early muscle degeneration and muscle function in the course are of great clinical and scientific importance.
MSOT has already been demonstrated to be a potential monitoring tool in different diseases. However, it has not yet been investigated to what extent 1) previous physical activity 2) different measuring ranges at the muscle, 3) longitudinal measurements and 4) intra- and interoperative variability influences the measured results. In particular, molecular changes immediately after the 6-MWT are relevant for studies in patients with DMD.
In this first pilot study, the investigators want to investigate in healthy adults, whether increased exercise changes the hemoglobin values, whether the collagen content remains constant and whether repeated measurements at different muscle positions by different investigators provide consistent results over time. This information is indispensable for future studies of children with muscular diseases in order to be able to make statements about disease progression or even therapy response.
- Conditions
- Muscular Diseases
- Being tested
- Multispectral Optoacoustic Tomography
- Keywords
- Muscular Diseases, Duchenne muscular disease, MSOT
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic TomographyDevice
Non-invasive transcutaneous imaging of subcellular muscle components
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Multispectral Optoacoustic Tomography (MSOT) of proximal and distal leg muscles (total of 12 sites: left and right, 3 measurement points of Musculus quadriceps, and 3 measurement points of Musculus triceps surae) before and after the 6-Minute-Walk-Test by to independent investigators. Repetition of the same protocol after 14 days. Receives: Device: Multispectral Optoacoustic Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular collagen content
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
Measured: one time point ( 2 measurements on day 1)
Muscular myo-/hemoglobin content
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
Measured: one time point ( 2 measurements on day 1)
Secondary outcomes (18)
Muscular oxygenated and deoxygenated myo-/hemoglobin content
Quantitative oxygenated and deoxygenated myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT and after 14 days.
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual collagen content
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) compared between three different points in one muscle of one healthy volunteer
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual myo-/hemoglobin content
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) compared between three different points in one muscle of one healthy volunteer
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual oxygenated and deoxygenated myo-/hemoglobin content
Quantitative oxygenated and deoxygenated myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) compared between three different points in one muscle of one healthy volunteer
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular collagen content in men and women
Quantitative collagen signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular myo-/hemoglobin content in men and women
Quantitative myo-/hemoglobin signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular oxygenated and deoxygenated myo-/hemoglobin content in men and women
Quantitative oxygenated and deoxygenated myo-/hemoglobin signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Correlation of collagen signal with the 6-MWT
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in Healthy volunteers before and after exercise correlated with the 6-MWT
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Correlation of myo-/hemoglobin signal with the 6-MWT
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in Healthy volunteers before and after exercise correlated with the 6-MWT
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Correlation of oxygenated and deoxygenated myo-/hemoglobin signal with the 6-MWT
Quantitative oxygenated and deoxygenated myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in Healthy volunteers before and after exercise correlated with the 6-MWT
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interrater reliability of collagen content
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers before and after 6-MWT and after 14 days compared between to investigators
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interrater reliability of myo-/hemoglobin content
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers before and after 6-MWT and after 14 days compared between to investigators
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interrater reliability of oxygenated and deoxygenated myo-/hemoglobin content
Quantitative oxygenated and deoxygenated myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers before and after 6-MWT and after 14 days compared between to investigators
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interreader reliability of collagen content
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers before and after 6-MWT and after 14 days compared between to readers
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interreader reliability of myo-/hemoglobin content
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers before and after 6-MWT and after 14 days compared between to readers
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interreader reliability of oxygenated and deoxygenated myo-/hemoglobin content
Quantitative oxygenated and deoxygenated myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers before and after 6-MWT and after 14 days compared between to readers
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular collagen content over time period
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared between day 1 and after 14 days.
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular myo-/hemoglobin content over time period
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared between day 1 and after 14 days.
Measured: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start14 Oct 2019
- Primary completion11 Nov 2019
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Regensburger, Dr., Principal investigator, Department of Pediatrics and Adolescent Medicine, University of ErlangenFerdinand Knieling, Dr., Principal investigator, Department of Pediatrics and Adolescent Medicine, University of Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979157
- Sponsor's protocol ID
- 169_19B
- Acronym
- MSOT_muscles
- Status last verified
- Jul 2020
- First submitted
- 3 Jun 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows: * Individual participant data will not be available * Study Protocol and Statistical Analysis Plan will be available * The data will be available beginning 9 months and ending 36 months following article publication. * The data will be available to researchers who provide a methodologically sound proposal. * The data will be available for individual participant data for meta-analysis, only. * Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de. Restrictions may apply due to patient privacy and the General Data Protection Regulation.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time
- ClinicalTrials.gov ID
- NCT03979157
- Acronym / sponsor ID
- MSOT_muscles / 169_19B
- Conditions
- Muscular Diseases
- Keywords
- Muscular Diseases, Duchenne muscular disease, MSOT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 7 Jun 2019 (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.
This study aims to determine hemoglobin and collagen levels in muscles before and after exercise, and over time, using Multispectral Optoacoustic Tomography (MSOT). During MSOT, a transducer is placed on the skin similar to a conventional sonography and instead of sound, energy is supplied to the tissue by means of light flashes. This leads to a constant change of minimal expansions and contractions (thermoelastic expansion) of individual tissue constituents or molecules. The resulting sound waves can then be detected by the same examination unit.
Detailed description
Duchenne muscular dystrophy (DMD) is one of the most common progressive childhood muscle diseases with an incidence of 1 in 3500 male newborns and is associated primarily with decreased life expectancy. Pathogenetically, there is a deficiency of dystrophin, a structural protein of the sarcolemma, which is caused by mutations (usually deletions) of the dystrophin gene (Xp21.3-p21.2). The result of dystrophin deficiency is a necrosis of muscle cells that are replaced by connective tissue and adipose tissue. Clinical scores (6-minute walk test, 6MWT) and MRI studies to characterize the degenerative changes of skeletal muscle in the early stages are available for the quantitative assessment of the disease progression as well as therapy effects, the significance of which is controversially discussed. However, the highly sensitive assessment of gene therapy effects will become increasingly important in the future. Sensitive, non-invasive methods for the detection of early muscle degeneration and muscle function in the course are of great clinical and scientific importance.
MSOT has already been demonstrated to be a potential monitoring tool in different diseases. However, it has not yet been investigated to what extent 1) previous physical activity 2) different measuring ranges at the muscle, 3) longitudinal measurements and 4) intra- and interoperative variability influences the measured results. In particular, molecular changes immediately after the 6-MWT are relevant for studies in patients with DMD.
In this first pilot study, the investigators want to investigate in healthy adults, whether increased exercise changes the hemoglobin values, whether the collagen content remains constant and whether repeated measurements at different muscle positions by different investigators provide consistent results over time. This information is indispensable for future studies of children with muscular diseases in order to be able to make statements about disease progression or even therapy response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: Multispectral Optoacoustic TomographyMultispectral Optoacoustic Tomography (MSOT) of proximal and distal leg muscles (total of 12 sites: left and right, 3 measurement points of Musculus quadriceps, and 3 measurement points of Musculus triceps surae) before and after the 6-Minute-Walk-Test by to independent investigators. Repetition of the same protocol after 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years of age
Key exclusion criteria (3 listed)
- any reference to a myopathy
- pregnancy
- tattoo in the scanning region
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 |
|---|---|---|
| Multispectral Optoacoustic TomographyNon-invasive transcutaneous imaging of subcellular muscle components | Device | Healthy Volunteers |
Primary outcome
Muscular collagen content
Time frame: one time point ( 2 measurements on day 1)
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
Muscular myo-/hemoglobin content
Time frame: one time point ( 2 measurements on day 1)
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
18 secondary outcomes
Muscular oxygenated and deoxygenated myo-/hemoglobin content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual collagen content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual myo-/hemoglobin content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual oxygenated and deoxygenated myo-/hemoglobin content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular collagen content in men and women
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular myo-/hemoglobin content in men and women
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular oxygenated and deoxygenated myo-/hemoglobin content in men and women
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Correlation of collagen signal with the 6-MWT
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Correlation of myo-/hemoglobin signal with the 6-MWT
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Correlation of oxygenated and deoxygenated myo-/hemoglobin signal with the 6-MWT
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interrater reliability of collagen content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interrater reliability of myo-/hemoglobin content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interrater reliability of oxygenated and deoxygenated myo-/hemoglobin content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interreader reliability of collagen content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interreader reliability of myo-/hemoglobin content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Interreader reliability of oxygenated and deoxygenated myo-/hemoglobin content
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular collagen content over time period
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular myo-/hemoglobin content over time period
Time frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
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 7 Jul 2020.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows: * Individual participant data will not be available * Study Protocol and Statistical Analysis Plan will be available * The data will be available beginning 9 months and ending 36 months following article publication. * The data will be available to researchers who provide a methodologically sound proposal. * The data will be available for individual participant data for meta-analysis, only. * Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de. Restrictions may apply due to patient privacy and the General Data Protection Regulation.
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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.
Adrian Regensburger, Dr. principal investigator
Department of Pediatrics and Adolescent Medicine, University of Erlangen
Ferdinand Knieling, Dr. principal investigator
Department of Pediatrics and Adolescent Medicine, University of Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispectral Optoacoustic Tomography in people with Muscular Diseases, run by University of Erlangen-Nürnberg Medical School 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 3 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 7 Jul 2020. 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?
Muscular collagen content (time frame: one time point ( 2 measurements on day 1)). The study lists 2 primary outcomes in all. 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 7 Jul 2020.