Muscular DiseasesNCT04262570
Evaluation of Therapeutic Response in Spinal Muscular Atrophy Using Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)
A study testing Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI) in people with Muscular Diseases and Spinal Muscular Atrophy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This study aims to refine the capability of Multispectral Optoacoustic Tomography (MSOT) and Magnet Resonance Imaging (MRI) to characterise the molecular composition of muscle tissue non-invasively and to evaluate the therapeutic response in patients with spinal muscular atrophy (SMA) over time. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Muscular Diseases, Spinal Muscular Atrophy
- What is being tested?
- Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 25 Feb 2020to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Genetically confirmed SMA type III
- From age 14
- Willingness and ability to participate, sufficient knowledge of the german language to understand the declaration of consent, or if not possible, information of the patient in his/her mother tongue or English
- High probability that the patients will be able to fully participate in the study (defined by the ability to lie still for about 1 hour and follow any breathing commands) For therapy arm: • Medical indication for Spinraza® therapy; start of study before first administration Spinraza® administration For control arm: • No medical indication for Spinraza® therapy
Who cannot join
- Pregnancy
- Tattoo on the skin area to be examined
- General contraindications for MRT examinations
- Electrical implants like pacemakers or perfusion pumps
- Pronounced claustrophobia
- Study participants with ferromagnetic or electrically conductive implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, heart valves with metal parts, metal splinters, tattoos next to the eye, symmetrical tattoos on the extremities or steel implants must consult the study physician; they may not be able to be examined (relative contraindications for MRI).
- Non-approved concomitant medication: strongly sedating medication must be excluded, as intensive monitoring of bodily functions during ongoing imaging cannot be guaranteed and the active participation of the test person might be necessary.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, 91054
Alexandra Wagner, MD, +49 9131 8533118, alexandra.l.wagner@uk-erlangen.de
Ferdinand Knieling, MD, +49 9131 8533118, ferdinand.knieling@uk-erlangen.de
About this study
This study aims to refine the capability of Multispectral Optoacoustic Tomography (MSOT) and Magnet Resonance Imaging (MRI) to characterise the molecular composition of muscle tissue non-invasively and to evaluate the therapeutic response in patients with spinal muscular atrophy (SMA) over time.
Read the detailed description
SMA is an autosomal-recessive disorder, characterized by progressive muscle weakness and atrophy with an incidence of 1/10,000. The condition is caused by a homozygous deletion or mutation in the survival motor neuron 1 (SMN1), resulting in reduced expression of the survival motor neuron (SMN) protein. This leads to the degeneration of motor neurons in the spinal cord and brain stem. A nearby related gene, survival motor neuron 2 (SMN2), could partially compensate the loss of SMN1. Individuals with a higher copy number of SMN2 do in general have a milder phenotype. New therapeutic approaches, e.g. nusinersen (spinraza©), an antisense oligonucleotide medication that modulates pre-messenger RNA splicing of the survival motor neuron 2 (SMN2) gene, are promising to help the formerly incurable disease. However, most clinical trials lack primary outcomes other than clinical testing. Preliminary work shows that new methods such as multispectral optoacoustic tomography (MSOT) and magnetic resonance imaging (MRI) detect tissue changes very sensitively. Multispectral optoacoustic tomography (MSOT) is capable of visualizing the distribution of endogenous absorbers by initiating laser-induced thermoelastic expansion and detection of resulting pressure waves. This imaging technique enables the label-free detection and quantification of different endogenous chromophores. In addition to this technology, MRI imaging has advanced in the field of muscle diseases, with 23Na-MRI being the first example. With both methods, the molecular composition of muscle tissue can be determined non-invasively and quantitatively at the same time. In this first pilot study on patients with SMA, the investigators will now assess whether the differences in the muscle composition of SMA patients with or without therapy can be quantified and whether they can be used simultaneously as markers during therapy with nusinersen (spinraza©) . Ideally, both techniques can complement or validate each other. In the future, this could generate a completely new, non-invasive method for evaluating endogenous biomarkers for therapy response.
- Conditions
- Muscular Diseases, Spinal Muscular Atrophy
- Being tested
- Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)
- Keywords
- Muscular Diseases, Spinal Muscular Atrophy (SMA), Multispectral Optoacoustic Tomography (MSOT), Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Muscular Diseases, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)Device
Non-invasive transcutaneous imaging of molecular muscle components
| Study group | Role | What they receive |
|---|---|---|
| SMA patients (therapy arm) | Experimental | * Multispectral Optoacoustic Tomography (MSOT) of muscles (left and right, total 4 sites) leg proximal: Musculus quadriceps, distal: Musculus triceps surae arm proximal: Musculus biceps, distal: forearm flexors;
* Magnetic Resonance Imaging (MRI) of lower leg
* Physical assessment/milestones: expanded Hammersmith functional motor scale (HFMSE)/ Revised Upper Limb Module (RULM)/ 6-minute-walking-test (6-MWT) Receives: Device: Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI) |
| SMA patients (control arm) | Active comparator | * Multispectral Optoacoustic Tomography (MSOT) of muscles (left and right, total 4 sites) leg proximal: Musculus quadriceps, distal: Musculus triceps surae arm proximal: Musculus biceps, distal: forearm flexors;
* Magnetic Resonance Imaging (MRI) of lower leg
* Physical assessment/milestones: expanded Hammersmith functional motor scale (HFMSE)/ Revised Upper Limb Module (RULM)/ 6-minute-walking-test (6-MWT) Receives: Device: Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of muscle structure under therapy and change from baseline over time
Comparison of the molecular muscle structure determined by MSOT and MRI in patients with SMA with and without treatment and evaluation of changes from baseline over time
Measured: 3 time points (at 0,2, and 12 months)
Secondary outcomes (17)
Muscular lipid content
Quantitative lipid signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in patients with SMA with and without therapy and change over time Units: arbitrary units (a.u.)
Measured: 3 time points (at 0,2, and 12 months)
Muscular collagen content
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in patients with SMA with and without therapy and change over time Units: arbitrary units (a.u.)
Measured: 3 time points (at 0,2, and 12 months)
Muscular hemo-/myoglobin content
Quantitative hemo/myoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in patients with SMA with and without therapy and change over time Units: arbitrary units (a.u.)
Measured: 3 time points (at 0,2, and 12 months)
Muscular de-/oxygenated hemo-/myoglobin content
Quantitative de-/oxygenated hemo-/myoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in patients with SMA with and without therapy and change over time Units: arbitrary units (a.u.)
Measured: 3 time points (at 0,2, and 12 months)
Ratio of lipid to hemo/myoglobin signal or collagen to hemo/myoglobin signal
Ratio of quantitative lipid signal to hemo/myoglobin signal or collagen signal to hemo/myoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in patients with SMA with and without therapy and change over time
Measured: 3 time points (at 0,2, and 12 months)
T1 relaxation time
T1 relaxation time determined by Magnetic Resonance Imaging (MRI) in patients with SMA with and without therapy and change over time
Measured: 3 time points (at 0,2, and 12 months)
T2 relaxation time
T2 relaxation time determined by Magnetic Resonance Imaging (MRI) in patients with SMA with and without therapy and change over time
Measured: 3 time points (at 0,2, and 12 months)
Fat-water percentage
Fat-water percentage determined by Magnetic Resonance Imaging (MRI) in patients with SMA with and without therapy and change over time
Measured: 3 time points (at 0,2, and 12 months)
Sodium concentration
Sodium concentration determined by Magnetic Resonance Imaging (MRI) in patients with SMA with and without therapy and change over time
Measured: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data with therapy status
Correlation of the quantitative lipid/collagen/hemo/myoglobin and de-/oxygenated hemo-/myoglobin content determined by MSOT in patients with and without therapy and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data with clinical data (age/disease duration)
Correlation of lipid/collagen/haemo/myoglobin and de-/oxygenated hemo-/myoglobin content determined by MSOT with disease duration/patient age and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data with physical assessment (HFMSE/RULM/6-MWT)
Correlation of lipid/collagen/haemo/myoglobin and de-/oxygenated hemo-/myoglobin content determined by MSOT with HFMSE/Revised Upper Limb Module/6-MWT and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Correlation of MRI data with therapy status
Correlation of T1 relaxation time/T2 relaxation time/fat water portion/sodium concentration in patients with and without therapy and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Correlation of MRI data with clinical data (age/disease duration)
Correlation of T1 relaxation time/T2 relaxation time/fat water portion/sodium concentration with disease duration and patient age and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Correlation of MRI data with physical assessment (HFMSE/RULM/6-MWT)
Correlation of T1 relaxation time/T2 relaxation time/fat water portion/sodium concentration with HFMSE/Revised Upper Limb Module/6-MWT and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data and MRI data
Correlation of MSOT determined lipid/collagen/haemo/myoglobin and de-/oxygenated hemo-/myoglobin content and MRI derived T1 relaxation time/T2 relaxation time/fat water portion/sodium concentration and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Side differences
Measurement of the signal differences in right / left comparison derived by Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI) and evaluation of change over time
Measured: 3 time points (at 0,2, and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start25 Feb 2020
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ferdinand Knieling, MD, Principal investigator, University Hospital Erlangen, Department of Pediatric and Adolescent MedicineMatthias Türk, MD, Principal investigator, University Hospital Erlangen, Department of NeurologyArmin Nagel, MD, Principal investigator, University Hospital Erlangen, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262570
- Sponsor's protocol ID
- 453_19B
- Status last verified
- Feb 2020
- First submitted
- 27 Jan 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Response in Spinal Muscular Atrophy Using Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT04262570
- Acronym / sponsor ID
- 453_19B
- Conditions
- Muscular Diseases, Spinal Muscular Atrophy
- Keywords
- Muscular Diseases, Spinal Muscular Atrophy (SMA), Multispectral Optoacoustic Tomography (MSOT), Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to refine the capability of Multispectral Optoacoustic Tomography (MSOT) and Magnet Resonance Imaging (MRI) to characterise the molecular composition of muscle tissue non-invasively and to evaluate the therapeutic response in patients with spinal muscular atrophy (SMA) over time.
Detailed description
SMA is an autosomal-recessive disorder, characterized by progressive muscle weakness and atrophy with an incidence of 1/10,000. The condition is caused by a homozygous deletion or mutation in the survival motor neuron 1 (SMN1), resulting in reduced expression of the survival motor neuron (SMN) protein. This leads to the degeneration of motor neurons in the spinal cord and brain stem. A nearby related gene, survival motor neuron 2 (SMN2), could partially compensate the loss of SMN1. Individuals with a higher copy number of SMN2 do in general have a milder phenotype. New therapeutic approaches, e.g. nusinersen (spinraza©), an antisense oligonucleotide medication that modulates pre-messenger RNA splicing of the survival motor neuron 2 (SMN2) gene, are promising to help the formerly incurable disease. However, most clinical trials lack primary outcomes other than clinical testing. Preliminary work shows that new methods such as multispectral optoacoustic tomography (MSOT) and magnetic resonance imaging (MRI) detect tissue changes very sensitively. Multispectral optoacoustic tomography (MSOT) is capable of visualizing the distribution of endogenous absorbers by initiating laser-induced thermoelastic expansion and detection of resulting pressure waves. This imaging technique enables the label-free detection and quantification of different endogenous chromophores. In addition to this technology, MRI imaging has advanced in the field of muscle diseases, with 23Na-MRI being the first example. With both methods, the molecular composition of muscle tissue can be determined non-invasively and quantitatively at the same time. In this first pilot study on patients with SMA, the investigators will now assess whether the differences in the muscle composition of SMA patients with or without therapy can be quantified and whether they can be used simultaneously as markers during therapy with nusinersen (spinraza©) . Ideally, both techniques can complement or validate each other. In the future, this could generate a completely new, non-invasive method for evaluating endogenous biomarkers for therapy response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMA patients (therapy arm) | Experimental | Device: Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)* Multispectral Optoacoustic Tomography (MSOT) of muscles (left and right, total 4 sites) leg proximal: Musculus quadriceps, distal: Musculus triceps surae arm proximal: Musculus biceps, distal: forearm flexors; * Magnetic Resonance Imaging (MRI) of lower leg * Physical assessment/milestones: expanded Hammersmith functional motor scale (HFMSE)/ Revised Upper Limb Module (RULM)/ 6-minute-walking-test (6-MWT) |
| SMA patients (control arm) | Active comparator | Device: Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)* Multispectral Optoacoustic Tomography (MSOT) of muscles (left and right, total 4 sites) leg proximal: Musculus quadriceps, distal: Musculus triceps surae arm proximal: Musculus biceps, distal: forearm flexors; * Magnetic Resonance Imaging (MRI) of lower leg * Physical assessment/milestones: expanded Hammersmith functional motor scale (HFMSE)/ Revised Upper Limb Module (RULM)/ 6-minute-walking-test (6-MWT) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Genetically confirmed SMA type III
- From age 14
- Willingness and ability to participate, sufficient knowledge of the german language to understand the declaration of consent, or if not possible, information of the patient in his/her mother tongue or English
- High probability that the patients will be able to fully participate in the study (defined by the ability to lie still for about 1 hour and follow any breathing commands) For therapy arm: • Medical indication for Spinraza® therapy; start of study before first administration Spinraza® administration For control arm: • No medical indication for Spinraza® therapy
Key exclusion criteria (7 listed)
- Pregnancy
- Tattoo on the skin area to be examined
- General contraindications for MRT examinations
- Electrical implants like pacemakers or perfusion pumps
- Pronounced claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)Non-invasive transcutaneous imaging of molecular muscle components | Device | SMA patients (control arm), SMA patients (therapy arm) |
Primary outcome
Evaluation of muscle structure under therapy and change from baseline over time
Time frame: 3 time points (at 0,2, and 12 months)
Comparison of the molecular muscle structure determined by MSOT and MRI in patients with SMA with and without treatment and evaluation of changes from baseline over time
17 secondary outcomes
Muscular lipid content
Time frame: 3 time points (at 0,2, and 12 months)
Muscular collagen content
Time frame: 3 time points (at 0,2, and 12 months)
Muscular hemo-/myoglobin content
Time frame: 3 time points (at 0,2, and 12 months)
Muscular de-/oxygenated hemo-/myoglobin content
Time frame: 3 time points (at 0,2, and 12 months)
Ratio of lipid to hemo/myoglobin signal or collagen to hemo/myoglobin signal
Time frame: 3 time points (at 0,2, and 12 months)
T1 relaxation time
Time frame: 3 time points (at 0,2, and 12 months)
T2 relaxation time
Time frame: 3 time points (at 0,2, and 12 months)
Fat-water percentage
Time frame: 3 time points (at 0,2, and 12 months)
Sodium concentration
Time frame: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data with therapy status
Time frame: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data with clinical data (age/disease duration)
Time frame: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data with physical assessment (HFMSE/RULM/6-MWT)
Time frame: 3 time points (at 0,2, and 12 months)
Correlation of MRI data with therapy status
Time frame: 3 time points (at 0,2, and 12 months)
Correlation of MRI data with clinical data (age/disease duration)
Time frame: 3 time points (at 0,2, and 12 months)
Correlation of MRI data with physical assessment (HFMSE/RULM/6-MWT)
Time frame: 3 time points (at 0,2, and 12 months)
Correlation of MSOT data and MRI data
Time frame: 3 time points (at 0,2, and 12 months)
Side differences
Time frame: 3 time points (at 0,2, and 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdinand Knieling, MD principal investigator
University Hospital Erlangen, Department of Pediatric and Adolescent Medicine
Matthias Türk, MD principal investigator
University Hospital Erlangen, Department of Neurology
Armin Nagel, MD principal investigator
University Hospital Erlangen, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI) in people with Muscular Diseases and Spinal Muscular Atrophy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Wagner, MD (+49 9131 85 33118, alexandra.l.wagner@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of muscle structure under therapy and change from baseline over time (time frame: 3 time points (at 0,2, and 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.