Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications (MRS VALIDATION)

June 6, 2023 updated by: AdventHealth Translational Research Institute
The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

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
        • Principal Investigator:
          • Heather Cornnell, PhD
        • Contact:
          • Recruitment Manager
          • Phone Number: 407-303-7100
          • Email: tri@flhosp.org

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

12 years to 89 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A healthy individual, who is willing and able to undergo MR imaging and spectroscopy for up to two hours at a time

Description

Inclusion Criteria:

  • Male or female
  • Age 12 - 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 MRI scan due to claustrophobia or other reason.
  • Serious mental illness that might preclude subject's ability to comply with study treatment
  • Life expectancy of less than 1 year
  • Are pregnant or plan on becoming pregnant in the next 8 weeks.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whole body fat quantification
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat Microstructure
Time Frame: 1 hour
A high resolution image of the structure of fat tissue.
1 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow high resolution imaging
Time Frame: 1 hour
Image of the movement of fluids in the area being imaged.
1 hour
Intramyocellular fat quantification
Time Frame: 45 minutes
Use to determine the amount and types of fat inside muscle and liver.
45 minutes
Intrahepatic fat quantification
Time Frame: 45 minutes
A measure of the amount of fat in the liver.
45 minutes

Collaborators and Investigators

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

Sponsor

AdventHealth Translational Research Institute

Investigators

  • 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

February 1, 2012

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimated)

January 26, 2016

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

  • TRIMD FH 306624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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