Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)
MSOT_muscles
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2020
CompletedJuly 7, 2020
July 1, 2020
28 days
June 3, 2019
July 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (18)
Muscular oxygenated and deoxygenated myo-/hemoglobin content
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual collagen content
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual myo-/hemoglobin content
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Intraindividual oxygenated and deoxygenated myo-/hemoglobin content
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
Muscular collagen content in men and women
multiple time points ( 2 measurements on day 1 and 2 measurements on day 15)
- +13 more secondary outcomes
Study Arms (1)
Healthy Volunteers
EXPERIMENTALMultispectral 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.
Interventions
Non-invasive transcutaneous imaging of subcellular muscle components
Eligibility Criteria
You may qualify if:
- \>18 years of age
You may not qualify if:
- any reference to a myopathy
- pregnancy
- tattoo in the scanning region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Erlangen
Erlangen, Bavaria, 91054, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2019
First Posted
June 7, 2019
Study Start
October 14, 2019
Primary Completion
November 11, 2019
Study Completion
June 23, 2020
Last Updated
July 7, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 36 months after publication
- Access Criteria
- Resonable request
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.