NCT02969603

Brief 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 distribution within exercising skeletal muscle.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

April 14, 2016

Last Update Submit

November 16, 2016

Conditions

Healthy

Keywords

PET/MRImuscular activity11C-acetate

Outcome Measures

Primary Outcomes (2)

  • Assessment of musculoskeletal systems in motion

    an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation

    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

    though study completion, an average of 2 years

Secondary Outcomes (1)

  • Measurement of the in vivo function of the muscle

    though study completion, an average of 2 years

Study Arms (2)

Healthy volunteers- MRI

OTHER

MRI scan for morphological assessment of muscle structures and anatomy

Other: Magnetic Resonance Imaging

Healthy Volunteers- PET/MRI

OTHER

The volunteers will undergo a combined \[11C\]acetate PET/MRI scan

Other: Magnetic Resonance combined with Positron Emission Tomography

Interventions

Magnetic Resonance ImagingOTHER

Magnetic Resonance Imaging as reference

Healthy volunteers- MRI
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

Healthy Volunteers- PET/MRI

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).
  • 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 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).

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Medecine Nucléaire et Imagerie moléculaire- HUG

Geneva, 1205, Switzerland

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Osman Ratib, Pr.

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 14, 2016

First Posted

November 21, 2016

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

CH(1)