Magnetic Resonance & Optical Spectroscopy Validation

Recruiting

• Conditions: Magnetic Resonance Spectroscopy; Validation Studies

• Registration Number: NCT01827527
• Lead Sponsor: AdventHealth Translational Research Institute

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of oxygen uptake	Hour 2	OS will be used to measure the oxygen (O2) uptake by following the rate of Hb-O2 and Mb-O2 deoxygenation during ischemia. The rate of the depletion of these O2 stores measures the rate of O2 uptake by the mitochondria. The Horbia Jobin Yvon optical system will be used. The OS acquisition procedure has been thoroughly described by Marcinek et.al
Rate of phosphocreatine (PCr) decay	Hour 2	The PCr decay (rate of PCr breakdown during ischemia) will be used to measure the ATP turnover rates (ATPase).; After the baseline is established, the volunteer will be asked to perform contractions of the quadriceps (by slight kicking) for up to 45 seconds.; . After kicking is stopped, the volunteer will remain still for an additional 5 minutes in order to allow the PCr peak to return to baseline. The ATPase experiment will also be performed by acquiring 31P Spectra every 6 seconds.

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States