Magnetic Resonance & Optical Spectroscopy Validation

June 6, 2023 updated by: AdventHealth Translational Research Institute

Development and Validation of 31P Magnetic Resonance and Optical Spectroscopy for the Characterization of ATP in Whole Body Human Applications

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Recruitment Department
  • Phone Number: (407) 303-7100
  • Email: tri@flhosp.org

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Translational Research Institute for Metabolism and Diabetes
        • Contact:
          • Recruitment Department
          • Phone Number: 407-303-7100
          • Email: tri@flhosp.org
        • Principal Investigator:
          • Heather Cornnell, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy adult volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy Adult
This is a protocol development study, with no interventions or treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of phosphocreatine (PCr) decay
Time Frame: 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.
Hour 2
Rate of oxygen uptake
Time Frame: 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
Hour 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Steven R. Smith, MD, Translational Research Institute for Metabolism and Diabetes
  • Principal Investigator: Heather Cornnell, PhD, Translational Research Institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimated)

April 9, 2013

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRIMDFH 422234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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