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

NCT ID: NCT02663362

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2027-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Human Body Composition Human Body Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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

Outside standard MR instrumentation there will be no interventions.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AdventHealth Translational Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Cornnell, PhD

Role: PRINCIPAL_INVESTIGATOR

Translational Research Institute for Metabolism and Diabetes

Locations

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Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Recruitment Department

Role: CONTACT

407-303-7100

Facility Contacts

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Recruitment Manager

Role: primary

407-303-7100

References

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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.

Reference Type BACKGROUND
PMID: 18512846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20672389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12201436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14735429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11544279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9065913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8505893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17885193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15170826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19697152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14618433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17955571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11739089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16493125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15390229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11288037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11745976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10668050 (View on PubMed)

Related Links

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http://www.tri-md.org

Translational Research Institute for Metabolism and Diabetes

Other Identifiers

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TRIMD FH 306624

Identifier Type: -

Identifier Source: org_study_id

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