NCT02663362

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Feb 2012Jan 2027

Study Start

First participant enrolled

February 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

14.3 years

First QC Date

January 14, 2016

Last Update Submit

March 25, 2026

Conditions

Human Body CompositionHuman Body Function

Keywords

magnetic resonance imagingmagnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Whole body fat quantification

    1 hour

Secondary Outcomes (1)

  • Fat Microstructure

    1 hour

Other Outcomes (3)

  • Flow high resolution imaging

    1 hour

  • Intramyocellular fat quantification

    45 minutes

  • Intrahepatic fat quantification

    45 minutes

Interventions

To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips MagnetOTHER

Outside standard MR instrumentation there will be no interventions.

Eligibility Criteria

Age12 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

RECRUITING

Related Publications (18)

  • Tyler DJ, Hudsmith LE, Clarke K, Neubauer S, Robson MD. A comparison of cardiac (31)P MRS at 1.5 and 3 T. NMR Biomed. 2008 Oct;21(8):793-8. doi: 10.1002/nbm.1255.

    PMID: 18512846BACKGROUND

  • Muller HP, Raudies F, Unrath A, Neumann H, Ludolph AC, Kassubek J. Quantification of human body fat tissue percentage by MRI. NMR Biomed. 2011 Jan;24(1):17-24. doi: 10.1002/nbm.1549.

    PMID: 20672389BACKGROUND

  • Price RR, Allison J, Massoth RJ, Clarke GD, Drost DJ; NMR Task Group #8. Practical aspects of functional MRI (NMR Task Group #8). Med Phys. 2002 Aug;29(8):1892-912. doi: 10.1118/1.1494990.

    PMID: 12201436BACKGROUND

  • Noseworthy MD, Bulte DP, Alfonsi J. BOLD magnetic resonance imaging of skeletal muscle. Semin Musculoskelet Radiol. 2003 Dec;7(4):307-15. doi: 10.1055/s-2004-815678.

    PMID: 14735429BACKGROUND

  • Lebon V, Dufour S, Petersen KF, Ren J, Jucker BM, Slezak LA, Cline GW, Rothman DL, Shulman GI. Effect of triiodothyronine on mitochondrial energy coupling in human skeletal muscle. J Clin Invest. 2001 Sep;108(5):733-7. doi: 10.1172/JCI11775.

    PMID: 11544279BACKGROUND

  • Roser W, Beckmann N, Wiesmann U, Seelig J. Absolute quantification of the hepatic glycogen content in a patient with glycogen storage disease by 13C magnetic resonance spectroscopy. Magn Reson Imaging. 1996;14(10):1217-20. doi: 10.1016/s0730-725x(96)00243-3.

    PMID: 9065913BACKGROUND

  • Beckmann N, Fried R, Turkalj I, Seelig J, Keller U, Stalder G. Noninvasive observation of hepatic glycogen formation in man by 13C MRS after oral and intravenous glucose administration. Magn Reson Med. 1993 May;29(5):583-90. doi: 10.1002/mrm.1910290502.

    PMID: 8505893BACKGROUND

  • van der Meer RW, Doornbos J, Kozerke S, Schar M, Bax JJ, Hammer S, Smit JW, Romijn JA, Diamant M, Rijzewijk LJ, de Roos A, Lamb HJ. Metabolic imaging of myocardial triglyceride content: reproducibility of 1H MR spectroscopy with respiratory navigator gating in volunteers. Radiology. 2007 Oct;245(1):251-7. doi: 10.1148/radiol.2451061904.

    PMID: 17885193BACKGROUND

  • Schar M, Kozerke S, Boesiger P. Navigator gating and volume tracking for double-triggered cardiac proton spectroscopy at 3 Tesla. Magn Reson Med. 2004 Jun;51(6):1091-5. doi: 10.1002/mrm.20123.

    PMID: 15170826BACKGROUND

  • Hudsmith LE, Tyler DJ, Emmanuel Y, Petersen SE, Francis JM, Watkins H, Clarke K, Robson MD, Neubauer S. (31)P cardiac magnetic resonance spectroscopy during leg exercise at 3 Tesla. Int J Cardiovasc Imaging. 2009 Dec;25(8):819-26. doi: 10.1007/s10554-009-9492-8. Epub 2009 Aug 21.

    PMID: 19697152BACKGROUND

  • Shen W, Mao X, Wang Z, Punyanitya M, Heymsfield SB, Shungu DC. Measurement of intramyocellular lipid levels with 2-D magnetic resonance spectroscopic imaging at 1.5 T. Acta Diabetol. 2003 Oct;40 Suppl 1(Suppl 1):S51-4. doi: 10.1007/s00592-003-0026-x.

    PMID: 14618433BACKGROUND

  • Shen W, Mao X, Wolper C, Heshka S, Dashnaw S, Hirsch J, Heymsfield SB, Shungu DC. Reproducibility of single- and multi-voxel 1H MRS measurements of intramyocellular lipid in overweight and lean subjects under conditions of controlled dietary calorie and fat intake. NMR Biomed. 2008 Jun;21(5):498-506. doi: 10.1002/nbm.1218.

    PMID: 17955571BACKGROUND

  • Larson-Meyer DE, Newcomer BR, Hunter GR. Influence of endurance running and recovery diet on intramyocellular lipid content in women: a 1H NMR study. Am J Physiol Endocrinol Metab. 2002 Jan;282(1):E95-E106. doi: 10.1152/ajpendo.2002.282.1.E95.

    PMID: 11739089BACKGROUND

  • Larson-Meyer DE, Smith SR, Heilbronn LK, Kelley DE, Ravussin E, Newcomer BR; Look AHEAD Adipose Research Group. Muscle-associated triglyceride measured by computed tomography and magnetic resonance spectroscopy. Obesity (Silver Spring). 2006 Jan;14(1):73-87. doi: 10.1038/oby.2006.10.

    PMID: 16493125BACKGROUND

  • Positano V, Gastaldelli A, Sironi AM, Santarelli MF, Lombardi M, Landini L. An accurate and robust method for unsupervised assessment of abdominal fat by MRI. J Magn Reson Imaging. 2004 Oct;20(4):684-9. doi: 10.1002/jmri.20167.

    PMID: 15390229BACKGROUND

  • Smith SR, Lovejoy JC, Greenway F, Ryan D, deJonge L, de la Bretonne J, Volafova J, Bray GA. Contributions of total body fat, abdominal subcutaneous adipose tissue compartments, and visceral adipose tissue to the metabolic complications of obesity. Metabolism. 2001 Apr;50(4):425-35. doi: 10.1053/meta.2001.21693.

    PMID: 11288037BACKGROUND

  • Larson-Meyer DE, Newcomer BR, Hunter GR, Joanisse DR, Weinsier RL, Bamman MM. Relation between in vivo and in vitro measurements of skeletal muscle oxidative metabolism. Muscle Nerve. 2001 Dec;24(12):1665-76. doi: 10.1002/mus.1202.

    PMID: 11745976BACKGROUND

  • Larson-Meyer DE, Newcomer BR, Hunter GR, Hetherington HP, Weinsier RL. 31P MRS measurement of mitochondrial function in skeletal muscle: reliability, force-level sensitivity and relation to whole body maximal oxygen uptake. NMR Biomed. 2000 Jan;13(1):14-27. doi: 10.1002/(sici)1099-1492(200002)13:13.0.co;2-0.

    PMID: 10668050BACKGROUND

Related Links

Study Officials

  • Heather Cornnell, PhD

    Translational Research Institute for Metabolism and Diabetes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Department

CONTACT

407-303-7100tri@flhosp.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 26, 2016

Study Start

February 1, 2012

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)