ObesityPhase 1NCT02220426
Hyperpolarized Xenon-129 Magnetic Resonance Imaging and Spectroscopy of Brown Fat: Healthy Adult Volunteer Pilot Study
A Phase 1 study testing Xenon in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Xenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 1 Jul 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Biomedical Research Imaging Center
Chapel Hill, North Carolina, 27599-7513
About this study
Official title: 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.
Read the detailed description
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
- Obesity
- Being tested
- Xenon
- Keywords
- Brown adipose tissue, Hyperpolarized xenon gas MRI
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called Hyperpolarized xenon gas
Inhalation of hyperpolarized xenon gas
| Study group | Role | What they receive |
|---|---|---|
| Xenon inhalation | Other | Inhalation up to 5 doses of 750ml of hyperpolarized 129Xe gas Receives: Drug: Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brow Adipose Tissue Surface Area
For each subject, the brown adipose tissue (BAT) surface area is derived from 2D MR images acquired without slice selection, obtained before and during cold exposure. Each image consists of Nx × Ny pixels, each having an in-plane pixel area (Apixel, in millimeters squared) calculated as: Apixel=(FOVx/Nx)×(FOVy/Ny), where FOVx and FOXy are the field-of-view dimensions in millimeters in the x and y directions, respectively. BAT-positive pixels are defined as those whose signal intensity increases by more than 5% during cold stimulation relative to baseline.
The total BAT surface area (ABAT, in millimeters squared) is then computed as:
ABAT=NBAT×Apixel where NBAT is the number of BAT-positive pixels for each subject.
This approach yields the total in-plane area of activated BAT within the 2D field of view for each subject. The value obtained for all subjects was then averaged.
Measured: Day 1
Secondary outcomes (1)
Change in BAT Temperature
Change in BAT temperature (in degree Celsius) will be estimated from xenon nuclear magnetic resonance (NMR) spectra acquired at thermoneutrality and during cold exposure. Both proton (1H) and xenon (129Xe) spectra are required to perform the temperature calculation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study start1 Sep 2015
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Rosa Tamara Branca, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220426
- Sponsor's protocol ID
- 14-1211
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2014
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25453088
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02220426
- Acronym / sponsor ID
- 14-1211
- Conditions
- Obesity
- Keywords
- Brown adipose tissue, Hyperpolarized xenon gas MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xenon inhalation | Other | Drug: XenonInhalation up to 5 doses of 750ml of hyperpolarized 129Xe gas |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonAlso: Hyperpolarized xenon gasInhalation of hyperpolarized xenon gas | Drug | Xenon inhalation |
Primary outcome
Brow Adipose Tissue Surface Area
Time frame: Day 1
For each subject, the brown adipose tissue (BAT) surface area is derived from 2D MR images acquired without slice selection, obtained before and during cold exposure. Each image consists of Nx × Ny pixels, each having an in-plane pixel area (Apixel, in millimeters squared) calculated as: Apixel=(FOVx/Nx)×(FOVy/Ny), where FOVx and FOXy are the field-of-view dimensions in millimeters in the x and y directions, respectively. BAT-positive pixels are defined as those whose signal intensity increases by more than 5% during cold stimulation relative to baseline. The total BAT surface area (ABAT, in millimeters squared) is then computed as: ABAT=NBAT×Apixel where NBAT is the number of BAT-positive pixels for each subject. This approach yields the total in-plane area of activated BAT within the 2D field of view for each subject. The value obtained for all subjects was then averaged.
1 secondary outcome
Change in BAT Temperature
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25453088Branca 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.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Tamara Branca, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xenon in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brow Adipose Tissue Surface Area (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02220426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.