Clinical trial NCT03979157: Non-invasive Molecular Imaging of Muscle Structure (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
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Diseases
Keywords: Muscular Diseases
Duchenne muscular disease
MSOT
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age

Exclusion Criteria:

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

Primary outcomes:
measure: Muscular collagen content
timeFrame: one time point ( 2 measurements on day 1)
measure: Muscular myo-/hemoglobin content
timeFrame: one time point ( 2 measurements on day 1)
Secondary outcomes:
measure: Muscular oxygenated and deoxygenated myo-/hemoglobin content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Intraindividual collagen content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Intraindividual myo-/hemoglobin content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Intraindividual oxygenated and deoxygenated myo-/hemoglobin content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Muscular collagen content in men and women
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Muscular myo-/hemoglobin content in men and women
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Muscular oxygenated and deoxygenated myo-/hemoglobin content in men and women
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Correlation of collagen signal with the 6-MWT
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Correlation of myo-/hemoglobin signal with the 6-MWT
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Correlation of oxygenated and deoxygenated myo-/hemoglobin signal with the 6-MWT
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Interrater reliability of collagen content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Interrater reliability of myo-/hemoglobin content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Interrater reliability of oxygenated and deoxygenated myo-/hemoglobin content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Interreader reliability of collagen content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Interreader reliability of myo-/hemoglobin content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Interreader reliability of oxygenated and deoxygenated myo-/hemoglobin content
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Muscular collagen content over time period
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
measure: Muscular myo-/hemoglobin content over time period
timeFrame: multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
state: Bavaria
Study officials:
affiliation: Department of Pediatrics and Adolescent Medicine, University of Erlangen
name: Adrian Regensburger, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics and Adolescent Medicine, University of Erlangen
name: Ferdinand Knieling, Dr.
role: PRINCIPAL_INVESTIGATOR
References: