Using magnetic resonance and optical spectroscopy to study energy use in the body
Development and Validation of 31P Magnetic Resonance and Optical Spectroscopy for the Characterization of ATP in Whole Body Human Applications
This study is testing new imaging techniques to see how our bodies use energy, and it's for people who want to help improve our understanding of metabolism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | AdventHealth Translational Research Institute Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT01827527 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and refine techniques for utilizing magnetic resonance and optical spectroscopy to investigate how the body utilizes energy. The primary objective is to evaluate the reproducibility of acquiring multi-nuclear data using a new 3T Philips Magnet in conjunction with Optical Spectroscopy. Participants will undergo imaging procedures to collect data that may enhance our understanding of metabolic processes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18 to 89 who can walk 50 yards and are able to undergo MRI procedures.
Not a fit: Patients with internal metal medical devices or those who are claustrophobic may not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing energy metabolism in patients, potentially aiding in the diagnosis and treatment of metabolic disorders.
How similar studies have performed: While this study focuses on validating new techniques, similar approaches in magnetic resonance spectroscopy have shown promise in previous research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orlando, Florida
- Translational Research Institute for Metabolism and Diabetes — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Steven R. Smith, MD — Translational Research Institute for Metabolism and Diabetes
- Study coordinator: Recruitment Department
- Email: tri@flhosp.org
- Phone: (407) 303-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.