ObesityBAT_PET/MRINCT02237872
Detection of Brown Adipose Tissue by Magnetic Resonance Imaging
An observational study of Obesity and Brown Adipose Tissue, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
The primary goal of this study is to assess the accuracy of conventional fat fraction proton MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using [18F]-2-fluoro-2-deoxy-D-glucose (fluorodeoxyglucose) -PET as gold standard. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Brown Adipose Tissue
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jan 2015to 27 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult human with a BMI <28
Who may be able to join
- Each subject must be fully informed and have signed consent.
- BMI < 34
- Normal neurological and psychological development / able to give consent
- Willingness to participate in this study
Who cannot join
- Subjects less than 18 years of age
- Severe claustrophobia
- Women who are pregnant, nursing an infant or planning to become pregnant in the next 30 days
- People who have a condition that makes MRI unsafe for them (for example, cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron filings in your eyes or metal halo devices)
- Have had radiation therapy or chemotherapy in the 2 months prior to PET scan
- Subjects are taking medications that may interfere with BAT detection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Biomedical Research Imaging Center
Chapel Hill, North Carolina, 27599-7513
Biomedical Research Imaging Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Assessment of MRI Accuracy for the Detection of Brown Adipose Tissue Using [18F]-2-fluoro-2-deoxy-D-glucose (Fluorodeoxyglucose) -PET as a Gold Standard
The primary goal of this study is to assess the accuracy of conventional fat fraction proton MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using [18F]-2-fluoro-2-deoxy-D-glucose (fluorodeoxyglucose) -PET as gold standard.
In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed on a combined PET/MRI scanner under mild cold condition.
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.
The detection of this tissue in adult humans represents an unmet need. BAT is difficult to detect and measurements of tissue fat fraction performed by magnetic resonance imaging have been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated white adipose tissue and from muscle.
To this end, the objective of this study is to assess the accuracy of magnetic resonance fat fraction measurements for the detection of BAT volume in adult humans, while using PET with fluorodeoxyglucose as gold standard.
For this study subjects will undergo a combined MRI/PET scan. The scans will be done during stimulation of thermogenic activity by mild cold exposure.
- Conditions
- Obesity, Brown Adipose Tissue
- Keywords
- Brown Adipose Tissue, MRI and PET detection of brown adipose tissue
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers exposed to cold to activate brown fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average dice similarity coefficient
The average dice similarity coefficient will be measured to assess the overlap between MRI and PET maps
Measured: Up to 1 year after the imaging scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study start20 Jan 2015
- Primary completion27 Aug 2015
- Study completion27 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8 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
- NCT02237872
- Sponsor's protocol ID
- 14-1980
- Acronym
- BAT_PET/MRI
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2014
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of MRI Accuracy for the Detection of Brown Adipose Tissue Using [18F]-2-fluoro-2-deoxy-D-glucose (Fluorodeoxyglucose) -PET as a Gold Standard
- ClinicalTrials.gov ID
- NCT02237872
- Acronym / sponsor ID
- BAT_PET/MRI / 14-1980
- Conditions
- Obesity, Brown Adipose Tissue
- Keywords
- Brown Adipose Tissue, MRI and PET detection of brown adipose tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
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 assess the accuracy of conventional fat fraction proton MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using [18F]-2-fluoro-2-deoxy-D-glucose (fluorodeoxyglucose) -PET as gold standard.
In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed on a combined PET/MRI scanner under mild cold condition.
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.
The detection of this tissue in adult humans represents an unmet need. BAT is difficult to detect and measurements of tissue fat fraction performed by magnetic resonance imaging have been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated white adipose tissue and from muscle.
To this end, the objective of this study is to assess the accuracy of magnetic resonance fat fraction measurements for the detection of BAT volume in adult humans, while using PET with fluorodeoxyglucose as gold standard.
For this study subjects will undergo a combined MRI/PET scan. The scans will be done during stimulation of thermogenic activity by mild cold exposure.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy volunteers exposed to cold to activate brown fat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult human with a BMI <28
Key inclusion criteria (4 listed)
- Each subject must be fully informed and have signed consent.
- BMI < 34
- Normal neurological and psychological development / able to give consent
- Willingness to participate in this study
Key exclusion criteria (6 listed)
- Subjects less than 18 years of age
- Severe claustrophobia
- Women who are pregnant, nursing an infant or planning to become pregnant in the next 30 days
- People who have a condition that makes MRI unsafe for them (for example, cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron filings in your eyes or metal halo devices)
- Have had radiation therapy or chemotherapy in the 2 months prior to PET scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average dice similarity coefficient
Time frame: Up to 1 year after the imaging scan
The average dice similarity coefficient will be measured to assess the overlap between MRI and PET maps
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Brown Adipose Tissue, run by University of North Carolina, Chapel Hill at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average dice similarity coefficient (time frame: Up to 1 year after the imaging scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.