Clinical trial NCT01827527: Magnetic Resonance & Optical Spectroscopy Validation
Official title: Development and Validation of 31P Magnetic Resonance and Optical Spectroscopy for the Characterization of ATP in Whole Body Human Applications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Validation Studies
Magnetic Resonance Spectroscopy
Keywords: Adenosine Triphosphate
Validation
Magnetic Resonance Spectroscopy
Optical Spectroscopy
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult volunteers

Brief summary: The purpose of this study is to develop and refine techniques for using magnetic resonance and optical spectroscopy to investigate how your body uses energy.

Detailed description: Primary Study Objective:

To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet in conjunction with Optical Spectroscopy.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 - 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 magnetic resonance imaging (MRI) scan due to claustrophobia or other reason.
* Serious mental illness that might preclude subject's ability to comply with study treatment
* Are pregnant or plan on becoming pregnant in the next 8 weeks.
* History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Varicose Veins
* Known genetic factor (Factor V Leiden, etc.) or hypercoagulable state, including cancer, leukemia - such as chronic myelocytic leukemia (CML), hemoglobinopathies - such as sickle-cell disease and multiple myeloma and other proteinopathies.
* Diagnosed peripheral arterial or vascular disease
* Family history of primary DVT or PE
* Peripheral neuropathy
* History of chronic venous stasis or lower extremity edema
* Female taking hormonal birth control (oral or otherwise) AND smoker

Primary outcomes:
measure: Rate of phosphocreatine (PCr) decay
timeFrame: Hour 2
measure: Rate of oxygen uptake
timeFrame: Hour 2
Secondary outcomes:
Other outcomes:
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: Steven R. Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Translational Research Institute for Metabolism and Diabetes
name: Heather Cornnell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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