Skip to main content
OpenTrials
Completed

NCT Number: NCT03979157

Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years of age

Exclusion criteria

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

Treatment and study plan

Multispectral Optoacoustic Tomography

Device

Non-invasive transcutaneous imaging of subcellular muscle components

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: MSOT_muscles

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 7, 2019
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.