Clinical trial NCT02663362: Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications
Official title: Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Body Composition
Human Body Function
Keywords: magnetic resonance imaging
magnetic resonance spectroscopy
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A healthy individual, who is willing and able to undergo MR imaging and spectroscopy for up to two hours at a time

Brief summary: The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 12 - 89
* Healthy (self assessed)
* Weight under 350lbs
* Able to walk 50 yards without stopping
* Able to travel to hospital for study visits
* Able to follow a 3-step command
* Able to remain in Magnetic Resonance (MR) scanner for up to 2 hours

Exclusion Criteria:

* Have internal metal medical devices, including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws, metal fragments in your eye, or non-removable jewelry such as rings.
* Are unwilling or unable to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason.
* Serious mental illness that might preclude subject's ability to comply with study treatment
* Life expectancy of less than 1 year
* Are pregnant or plan on becoming pregnant in the next 8 weeks.

Primary outcomes:
measure: Whole body fat quantification
timeFrame: 1 hour
Secondary outcomes:
measure: Fat Microstructure
timeFrame: 1 hour
Other outcomes:
measure: Flow high resolution imaging
timeFrame: 1 hour
measure: Intramyocellular fat quantification
timeFrame: 45 minutes
measure: Intrahepatic fat quantification
timeFrame: 45 minutes
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: Translational Research Institute for Metabolism and Diabetes
name: Heather Cornnell, PhD
role: PRINCIPAL_INVESTIGATOR
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