Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)

Muscular Diseases Clinical Trial

— MSOT_muscles  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979157
• Other study ID #: 169_19B
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: July 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Muscular Diseases

Intervention

Device:
• Multispectral Optoacoustic Tomography
Non-invasive transcutaneous imaging of subcellular muscle components

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

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)