Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT02969603
Status:
UNKNOWN
Last Update Posted:
2016-11-21
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Leg Muscular Activity Using MRI and 11C-acetate PET/MRI. Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of musculoskeletal systems in motion', 'timeFrame': 'though study completion, an average of 2 years', 'description': 'an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation'}, {'measure': 'Distribution of acetate metabolism during exercise skeletal muscle', 'timeFrame': 'though study completion, an average of 2 years', 'description': '11C-acetate uptake (SUV and SUVratio with resting muscles) in contracting muscle, measured using muscle segmentation from MRI images'}], 'secondaryOutcomes': [{'measure': 'Measurement of the in vivo function of the muscle', 'timeFrame': 'though study completion, an average of 2 years', 'description': 'correlation between 11C-acetate uptake and contractile force measures (weight and duration of exercise)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PET/MRI', 'muscular activity', '11C-acetate'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMRI exam inclusion criteria\n\n* Male volunteer aged in the range 18 to 35 years.\n* Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.\n* Volunteers that could undergo 1h15 to 1h30 immobilization (MRI exam duration in time).\n\nPET/MRI exam inclusion criteria\n\n* Male volunteer aged in the range 18 to 35 years.\n* Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.\n* Volunteers that could undergo 1.5 to 2.0 hours immobilization (PET/MRI exam duration in time).\n* 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).\n\nExclusion criteria MRI exam exclusion criteria\n\n* Pre-existing neurological or muscular lesions on the legs.\n* Co morbidities impeding on the protocol comprehension or fulfilment.\n* Illnesses that do not allow to lay down on an examination table.\n* Pacemaker holder.\n* Metal implants that would preclude MRI imaging\n* 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.\n\nPET/MRI exam exclusion criteria\n\n* 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).\n* Pre-existing neurological or muscular lesions on the legs.\n* Co morbidities impeding on the protocol comprehension or fulfilment.\n* Illnesses that do not allow to lay down on an examination table.\n* Pacemaker holder.\n* Metal implants that would preclude MRI imaging\n* 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.'}, 'identificationModule': {'nctId': 'NCT02969603', 'briefTitle': 'Evaluation of Leg Muscular Activity Using MRI and 11C-acetate PET/MRI. Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Evaluation of Leg Muscular Activity Using Magnetic Resonance Imaging and 11C-acetate Positron Tomography (PET/MRI). Pilot Study', 'orgStudyIdInfo': {'id': '2013DR2115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy volunteers- MRI', 'description': 'MRI scan for morphological assessment of muscle structures and anatomy', 'interventionNames': ['Other: Magnetic Resonance Imaging']}, {'type': 'OTHER', 'label': 'Healthy Volunteers- PET/MRI', 'description': 'The volunteers will undergo a combined \\[11C\\]acetate PET/MRI scan', 'interventionNames': ['Other: Magnetic Resonance combined with Positron Emission Tomography']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'OTHER', 'description': 'Magnetic Resonance Imaging as reference', 'armGroupLabels': ['Healthy volunteers- MRI']}, {'name': 'Magnetic Resonance combined with Positron Emission Tomography', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Healthy Volunteers- PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Service de Medecine Nucléaire et Imagerie moléculaire- HUG', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Osman Ratib, Pr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osman Ratib', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Osman Ratib', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}