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

NCT ID: NCT02220426

Last Updated: 2025-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-07-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Xenon inhalation

Inhalation up to 5 doses of 750ml of hyperpolarized 129Xe gas

Group Type OTHER

Xenon

Intervention Type DRUG

Inhalation of hyperpolarized xenon gas

Interventions

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Xenon

Inhalation of hyperpolarized xenon gas

Intervention Type DRUG

Other Intervention Names

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Hyperpolarized xenon gas

Eligibility Criteria

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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 -Positron Emission Tomography (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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosa Tamara Branca, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Biomedical Research Imaging Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Branca RT, He T, Zhang L, Floyd CS, Freeman M, White C, Burant A. Detection of brown adipose tissue and thermogenic activity in mice by hyperpolarized xenon MRI. Proc Natl Acad Sci U S A. 2014 Dec 16;111(50):18001-6. doi: 10.1073/pnas.1403697111. Epub 2014 Dec 1.

Reference Type RESULT
PMID: 25453088 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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14-1211

Identifier Type: -

Identifier Source: org_study_id

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