Hyperpolarized Xenon-129 Magnetic Resonance Imaging and Spectroscopy of Brown Fat: Healthy Adult Volunteer Pilot Study



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 60
Updated:7/5/2018
Start Date:September 1, 2015
End Date:August 2020
Contact:Kristine Baluyot
Email:kristine_baluyot@med.unc.edu
Phone:(919) 843-5420

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Phase 1 Study: Detection of Brown Adipose Tissue in Normal Volunteers Using a 3 Tesla (3T) Magnetic Resonance Imaging System and Hyperpolarized (HP) Xenon Gas

The primary goal of this study is to evaluate the feasibility of detecting Brown Adipose
Tissue (BAT) in healthy subjects by using hyperpolarized xenon gas MRI.

In this pilot study, MRI of BAT of healthy adult volunteers will be performed at 3 Tesla to
assess image quality using a prototype surface coil and pulse sequence following inhalation
of hyperpolarized 129Xe (xenon) gas at thermoneutrality and under mild cold condition.

The investigators are testing the abilities of xenon MRI to see brown adipose tissue and
detect its thermogenic activity.

In the fight against obesity, brown adipose tissue (BAT) is considered to be the newest
target. The hypothesis is that this tissue is partially responsible for the imbalance between
energy intake and energy expenditure that keeps lean people lean and obese people obese.

As the detection of this tissue in adult humans is difficult, this study aim to evaluate the
use of hyperpolarized xenon gas MRI for the detection of this tissue.

Hyperpolarized xenon gas MRI is currently used for lung ventilation studies. For this study
subjects will undergo an MRI scan for which they will also inhaled hyperpolarized xenon.
Scans will be done before and during stimulation of thermogenic activity by cold exposure,
while MR images and spectra will be acquired from the supraclavicular area. We expect that
the inhaled gas will diffuse into blood and eventually reach BAT in a manner proportional to
the metabolic activity of this tissue.

Objectives of this studies are:

- To detect BAT volume using hyperpolarized xenon MRI

- To detect BAT thermogenic activity by hyperpolarized xenon Nuclear Magnetic Resonance
(NMR) spectroscopy

Inclusion Criteria:

- Ability to give informed consent

- Willing to participate in this study

- Male or female ≥ 18 years of age at the time of the interview.

- Subject has no diagnosed pulmonary condition

- Subject has not smoked in the previous 5 years

- Smoking history, if any, is less than or equal to 5 pack-years

- Written informed consent (and assent when applicable) obtained from subject or
subject's

- legal representative and ability for subject to comply with the requirements of the
study

- Healthy subject that may or may not have undergone an fluorodeoxyglucose -PET scan

Exclusion Criteria:

- Any contraindication to MRI (presence of any non-removable metal implant, stents,
pacemaker, clips, staples, or piercings, etc. )

- Subject does not fit in the magnet

- Pregnancy or breast feeding

- Severe claustrophobia

- Subject is less than 18 years old

- MRI is contraindicated based on responses to MRI screening questionnaire

- Subject is pregnant or lactating

- Respiratory illness of a bacterial or viral etiology within 15 days of MRI

- Subject has received an investigational medicinal product (not including 129Xe) within
30 days of MRI

- Subject has any form of known cardiovascular disease

- Subject cannot hold their breath for 15 seconds

- Subject deemed unlikely to be able to comply with instructions during imaging

- Subject is taking beta blockers

- Subject underwent an fluorodeoxyglucose-PET examination less than one week before the
HP xenon MRI scan
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: Rosa Tamara Branca, PhD
Phone: 919-843-5420
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mi
from
Chapel Hill, NC
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