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出境医 / 临床实验 / Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles) (MSOT_muscles)
Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles) (MSOT_muscles)
Study Description
Brief 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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Muscular Diseases | Device: Multispectral Optoacoustic Tomography | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time |
| Actual Study Start Date : | October 14, 2019 |
| Actual Primary Completion Date : | November 11, 2019 |
| Actual Study Completion Date : | June 23, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Healthy Volunteers
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.
|
Device: Multispectral Optoacoustic Tomography
Non-invasive transcutaneous imaging of subcellular muscle components
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Muscular oxygenated and deoxygenated myo-/hemoglobin content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]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.
- Intraindividual collagen content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) compared between three different points in one muscle of one healthy volunteer
- Intraindividual myo-/hemoglobin content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) compared between three different points in one muscle of one healthy volunteer
- Intraindividual oxygenated and deoxygenated myo-/hemoglobin content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]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
- Muscular collagen content in men and women [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]Quantitative collagen signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
- Muscular myo-/hemoglobin content in men and women [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]Quantitative myo-/hemoglobin signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
- 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) ]Quantitative oxygenated and deoxygenated myo-/hemoglobin signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
- Correlation of collagen signal with the 6-MWT [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in Healthy volunteers before and after exercise correlated with the 6-MWT
- 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) ]Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in Healthy volunteers before and after exercise correlated with the 6-MWT
- 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) ]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
- Interrater reliability of collagen content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]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
- Interrater reliability of myo-/hemoglobin content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]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
- 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) ]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
- Interreader reliability of collagen content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]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
- Interreader reliability of myo-/hemoglobin content [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]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
- 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) ]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
- Muscular collagen content over time period [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared between day 1 and after 14 days.
- Muscular myo-/hemoglobin content over time period [ Time Frame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) ]Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared between day 1 and after 14 days.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- >18 years of age
Exclusion Criteria:
- any reference to a myopathy
- pregnancy
- tattoo in the scanning region
Contacts and Locations
Locations
| Germany | |
| University Hospital Erlangen | |
| Erlangen, Bavaria, Germany, 91054 | |
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
| Principal Investigator: | Adrian Regensburger, Dr. | Department of Pediatrics and Adolescent Medicine, University of Erlangen | |
| Principal Investigator: | Ferdinand Knieling, Dr. | Department of Pediatrics and Adolescent Medicine, University of Erlangen |
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 3, 2019 | ||||||||||||
| First Posted Date ICMJE | June 7, 2019 | ||||||||||||
| Last Update Posted Date | July 7, 2020 | ||||||||||||
| Actual Study Start Date ICMJE | October 14, 2019 | ||||||||||||
| Actual Primary Completion Date | November 11, 2019 (Final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | |||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles) | ||||||||||||
| Official Title ICMJE | Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time | ||||||||||||
| Brief 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 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||||||
| Condition ICMJE | Muscular Diseases | ||||||||||||
| Intervention ICMJE | Device: Multispectral Optoacoustic Tomography
Non-invasive transcutaneous imaging of subcellular muscle components
|
||||||||||||
| Study Arms ICMJE | Experimental: Healthy Volunteers
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.
Intervention: Device: Multispectral Optoacoustic Tomography
|
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Actual Enrollment ICMJE |
10 | ||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
| Actual Study Completion Date ICMJE | June 23, 2020 | ||||||||||||
| Actual Primary Completion Date | November 11, 2019 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Listed Location Countries ICMJE | Germany | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT03979157 | ||||||||||||
| Other Study ID Numbers ICMJE | 169_19B | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Erlangen-Nürnberg Medical School | ||||||||||||
| Study Sponsor ICMJE | University of Erlangen-Nürnberg Medical School | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| PRS Account | University of Erlangen-Nürnberg Medical School | ||||||||||||
| Verification Date | July 2020 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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