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Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)

Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03979157
Acronym
MSOT_muscles
Enrollment
10
Registered
2019-06-07
Start date
2019-10-14
Completion date
2020-06-23
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Diseases

Keywords

Muscular Diseases, Duchenne muscular disease, MSOT

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.

Interventions

Non-invasive transcutaneous imaging of subcellular muscle components

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* \>18 years of age

Exclusion criteria

* any reference to a myopathy * pregnancy * tattoo in the scanning region

Design outcomes

Primary

MeasureTime frameDescription
Muscular collagen contentone 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 contentone 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

MeasureTime frameDescription
Intraindividual myo-/hemoglobin contentmultiple 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 contentmultiple 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 womenmultiple 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 womenmultiple 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 womenmultiple 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-MWTmultiple 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-MWTmultiple 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-MWTmultiple 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
Muscular oxygenated and deoxygenated myo-/hemoglobin contentmultiple 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.
Interrater reliability of myo-/hemoglobin contentmultiple 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 contentmultiple 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 contentmultiple 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 contentmultiple 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 contentmultiple 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 periodmultiple 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 periodmultiple 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.
Interrater reliability of collagen contentmultiple 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
Intraindividual collagen contentmultiple 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026