Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles) (MSOT_muscles)
Primary Purpose
Muscular Diseases
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Multispectral Optoacoustic Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Muscular Diseases focused on measuring Muscular Diseases, Duchenne muscular disease, MSOT
Eligibility Criteria
Inclusion Criteria:
- >18 years of age
Exclusion Criteria:
- any reference to a myopathy
- pregnancy
- tattoo in the scanning region
Sites / Locations
- University Hospital Erlangen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Volunteers
Arm Description
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.
Outcomes
Primary Outcome Measures
Muscular collagen content
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared between day 1 and after 14 days.
Full Information
NCT ID
NCT03979157
First Posted
June 3, 2019
Last Updated
July 1, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03979157
Brief Title
Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)
Acronym
MSOT_muscles
Official Title
Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
June 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Diseases
Keywords
Muscular Diseases, Duchenne muscular disease, MSOT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Multispectral Optoacoustic Tomography
Intervention Description
Non-invasive transcutaneous imaging of subcellular muscle components
Primary Outcome Measure Information:
Title
Muscular collagen content
Description
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
Time Frame
one time point ( 2 measurements on day 1)
Title
Muscular myo-/hemoglobin content
Description
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
Time Frame
one time point ( 2 measurements on day 1)
Secondary Outcome Measure Information:
Title
Muscular oxygenated and deoxygenated myo-/hemoglobin content
Description
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.
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Intraindividual collagen content
Description
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) compared between three different points in one muscle of one healthy volunteer
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Intraindividual myo-/hemoglobin content
Description
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) compared between three different points in one muscle of one healthy volunteer
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Intraindividual oxygenated and deoxygenated myo-/hemoglobin content
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Muscular collagen content in men and women
Description
Quantitative collagen signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Muscular myo-/hemoglobin content in men and women
Description
Quantitative myo-/hemoglobin signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Muscular oxygenated and deoxygenated myo-/hemoglobin content in men and women
Description
Quantitative oxygenated and deoxygenated myo-/hemoglobin signal of muscles derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in healthy men compared to healthy women.
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Correlation of collagen signal with the 6-MWT
Description
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in Healthy volunteers before and after exercise correlated with the 6-MWT
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Correlation of myo-/hemoglobin signal with the 6-MWT
Description
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in Healthy volunteers before and after exercise correlated with the 6-MWT
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Correlation of oxygenated and deoxygenated myo-/hemoglobin signal with the 6-MWT
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Interrater reliability of collagen content
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Interrater reliability of myo-/hemoglobin content
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Interrater reliability of oxygenated and deoxygenated myo-/hemoglobin content
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Interreader reliability of collagen content
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Interreader reliability of myo-/hemoglobin content
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Interreader reliability of oxygenated and deoxygenated myo-/hemoglobin content
Description
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
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Muscular collagen content over time period
Description
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared between day 1 and after 14 days.
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Title
Muscular myo-/hemoglobin content over time period
Description
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared between day 1 and after 14 days.
Time Frame
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>18 years of age
Exclusion Criteria:
any reference to a myopathy
pregnancy
tattoo in the scanning region
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Regensburger, Dr.
Organizational Affiliation
Department of Pediatrics and Adolescent Medicine, University of Erlangen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ferdinand Knieling, Dr.
Organizational Affiliation
Department of Pediatrics and Adolescent Medicine, University of Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
36 months after publication
IPD Sharing Access Criteria
Resonable request
Learn more about this trial
Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)
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