Magnetic Resonance & Optical Spectroscopy Validation

AdventHealth Translational Research Institute

Status: Enrolling

Conditions: Validation Studies; Magnetic Resonance Spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT01827527

TRIMDFH 422234

Details and patient eligibility

About

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.

Full description

Primary Study Objective:

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Healthy Adult

Description:

This is a protocol development study, with no interventions or treatments.