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Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles) (MSOT_muscles)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979157
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979157


Locations
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Germany
University Hospital Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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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
  Study Documents (Full-Text)

Documents provided by University of Erlangen-Nürnberg Medical School:
Statistical Analysis Plan  [PDF] April 23, 2019
Study Protocol  [PDF] April 23, 2019

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03979157    
Other Study ID Numbers: 169_19B
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 36 months after publication
Access Criteria: Resonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Muscular Diseases
Duchenne muscular disease
MSOT
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases