Muscular Diseases Clinical Trial
— MSOT_musclesOfficial title:
Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time
NCT number | NCT03979157 |
Other study ID # | 169_19B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 14, 2019 |
Est. completion date | June 23, 2020 |
Verified date | July 2020 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 23, 2020 |
Est. primary completion date | November 11, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - >18 years of age Exclusion Criteria: - any reference to a myopathy - pregnancy - tattoo in the scanning region |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Erlangen | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscular collagen content | Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT. | one time point ( 2 measurements on day 1) | |
Primary | 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. | one time point ( 2 measurements on day 1) | |
Secondary | 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. | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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. | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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. | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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. | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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 | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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. | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) | |
Secondary | 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. | multiple time points ( 2 measurements on day 1 and 2 measurements on day 15) |
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