HealthyPhase 1/2NCT02969603
Evaluation of Leg Muscular Activity Using MRI and 11C-acetate PET/MRI. Pilot Study
A Phase 1/2 study testing Magnetic Resonance Imaging and Magnetic Resonance combined with Positron Emission Tomography in people with Healthy, run by Osman Ratib at 1 site in Switzerland.
Trial summary
The present study is conceived as a pilot study aimed to determine the efficiency of the newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid scan technique for muscular activity evaluation, creation of anatomic images of muscle activity and resolution of metabolic activity… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Magnetic Resonance Imaging and Magnetic Resonance combined with Positron Emission Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Dec 2016
- Phase
- Phase 1/2
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- MRI exam inclusion criteria
- Male volunteer aged in the range 18 to 35 years.
- Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.
- Volunteers that could undergo 1h15 to 1h30 immobilization (MRI exam duration in time).
- PET/MRI exam inclusion criteria
- Male volunteer aged in the range 18 to 35 years.
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- Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.
- Volunteers that could undergo 1.5 to 2.0 hours immobilization (PET/MRI exam duration in time).
- Volunteers should practice regular physical activity, defined as 50 min per day (in a single session), 2 days per week of physical activity as a minimum (no maximum is fixed).
Who cannot join
- Pre-existing neurological or muscular lesions on the legs.
- Co morbidities impeding on the protocol comprehension or fulfilment.
- Illnesses that do not allow to lay down on an examination table.
- Pacemaker holder.
- Metal implants that would preclude MRI imaging
- Claustrophobia: Subjects will be questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.
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- PET/MRI exam exclusion criteria
- Medical radiation exposure within the last five years (normal population should not be exposed to medical radiation higher or equal to 1 mSv per year).
- Pre-existing neurological or muscular lesions on the legs.
- Co morbidities impeding on the protocol comprehension or fulfilment.
- Illnesses that do not allow to lay down on an examination table.
- Pacemaker holder.
- Metal implants that would preclude MRI imaging
- Claustrophobia: Subjects will be questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service de Medecine Nucléaire et Imagerie moléculaire- HUG
Geneva, 1205
About this study
Official title: Evaluation of Leg Muscular Activity Using Magnetic Resonance Imaging and 11C-acetate Positron Tomography (PET/MRI). Pilot Study
The present study is conceived as a pilot study aimed to determine the efficiency of the newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid scan technique for muscular activity evaluation, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle.
- Conditions
- Healthy
- Being tested
- Magnetic Resonance Imaging, Magnetic Resonance combined with Positron Emission Tomography
- Keywords
- PET/MRI, muscular activity, 11C-acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Magnetic Resonance Imaging as reference
Magnetic Resonance combined with Positron Emission TomographyOther
Comparison with MRI only, to assess muscular activity, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers- MRI | Other | MRI scan for morphological assessment of muscle structures and anatomy Receives: Other: Magnetic Resonance Imaging |
| Healthy Volunteers- PET/MRI | Other | The volunteers will undergo a combined [11C]acetate PET/MRI scan Receives: Other: Magnetic Resonance combined with Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of musculoskeletal systems in motion
an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation
Measured: though study completion, an average of 2 years
Distribution of acetate metabolism during exercise skeletal muscle
11C-acetate uptake (SUV and SUVratio with resting muscles) in contracting muscle, measured using muscle segmentation from MRI images
Measured: though study completion, an average of 2 years
Secondary outcomes (1)
Measurement of the in vivo function of the muscle
correlation between 11C-acetate uptake and contractile force measures (weight and duration of exercise)
Measured: though study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startSep 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osman Ratib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osman Ratib, University Hospital, Geneva
- Investigators
- Osman Ratib, Pr., Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969603
- Sponsor's protocol ID
- 2013DR2115
- Status last verified
- Nov 2016
- First submitted
- 14 Apr 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Leg Muscular Activity Using Magnetic Resonance Imaging and 11C-acetate Positron Tomography (PET/MRI). Pilot Study
- ClinicalTrials.gov ID
- NCT02969603
- Acronym / sponsor ID
- 2013DR2115
- Conditions
- Healthy
- Keywords
- PET/MRI, muscular activity, 11C-acetate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Osman RatibUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- 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.
The present study is conceived as a pilot study aimed to determine the efficiency of the newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid scan technique for muscular activity evaluation, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers- MRI | Other | Other: Magnetic Resonance ImagingMRI scan for morphological assessment of muscle structures and anatomy |
| Healthy Volunteers- PET/MRI | Other | Other: Magnetic Resonance combined with Positron Emission TomographyThe volunteers will undergo a combined [11C]acetate PET/MRI scan |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- MRI exam inclusion criteria
- Male volunteer aged in the range 18 to 35 years.
- Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.
- Volunteers that could undergo 1h15 to 1h30 immobilization (MRI exam duration in time).
- PET/MRI exam inclusion criteria
Key exclusion criteria (14 listed)
- Pre-existing neurological or muscular lesions on the legs.
- Co morbidities impeding on the protocol comprehension or fulfilment.
- Illnesses that do not allow to lay down on an examination table.
- Pacemaker holder.
- Metal implants that would preclude MRI imaging
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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging as reference | Other | Healthy volunteers- MRI |
| Magnetic Resonance combined with Positron Emission TomographyComparison with MRI only, to assess muscular activity, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle | Other | Healthy Volunteers- PET/MRI |
Primary outcome
Assessment of musculoskeletal systems in motion
Time frame: though study completion, an average of 2 years
an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation
Distribution of acetate metabolism during exercise skeletal muscle
Time frame: though study completion, an average of 2 years
11C-acetate uptake (SUV and SUVratio with resting muscles) in contracting muscle, measured using muscle segmentation from MRI images
1 secondary outcome
Measurement of the in vivo function of the muscle
Time frame: though study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
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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.
Osman Ratib, Pr. principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Magnetic Resonance Imaging and Magnetic Resonance combined with Positron Emission Tomography in people with Healthy, run by Osman Ratib at 1 site in Switzerland.
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 9 inclusion and 14 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 21 Nov 2016. 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 Switzerland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of musculoskeletal systems in motion (time frame: though study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 21 Nov 2016.