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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon inhalation | Other | Inhalation up to 5 doses of 750ml of hyperpolarized 129Xe gas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | Inhalation of hyperpolarized xenon gas |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Tamara Branca, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedical Research Imaging Center | Chapel Hill | North Carolina | 27599-7513 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25453088 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xenon Inhalation | Inhalation of up to 5 doses of 750ml of hyperpolarized 129Xe gas Xenon: Inhalation of hyperpolarized xenon gas |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xenon Inhalation | Inhalation of up to 5 doses of 750ml of hyperpolarized 129Xe gas Xenon: Inhalation of hyperpolarized xenon gas |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No imaging data were collected for 9 participants because the Xenon signal did not reach the needed threshold required for imaging. | Posted | Mean | Standard Deviation | millimiters squared | Day 1 | 2-D images | 2-D images |
|
Within two minutes after xenon inhalation and continuing through and ending at one hour after the last xenon inhalation, a total of up to 1 hour in total.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xenon Inhalation | Inhalation of 5 doses of 750ml of hyperpolarized 129Xe gas Xenon: Inhalation of hyperpolarized xenon gas |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Restlessness | Nervous system disorders | Systematic Assessment |
This pilot study was conducted to optimize the magnetic resonance protocol for detecting hyperpolarized xenon gas dissolved in brown adipose tissue (BAT). As no prior human data were available, early participants were studied to refine the protocol and identify possible issues with the magnetic resonance imaging and spectroscopy protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rosa Tamara Branca, PhD | University of North Carolina at Chapel Hill | 9199622229 | rtbranca@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2014 | Nov 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Xenon Inhalation | Inhalation of 5 doses of 750ml of hyperpolarized 129Xe gas Xenon: Inhalation of hyperpolarized xenon gas |
|
|
| Secondary | 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. | Temperature measurements were not performed because the xenon and proton spectra were acquired with different magnet settings, which prevented alignment of the signals required for calculation. | Posted | Day 1 |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 12 |
| 13 |
| Numbness | Nervous system disorders | Systematic Assessment |
|
| Euphoria | Psychiatric disorders | Systematic Assessment |
|
| Tingling | Nervous system disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Device site discomfort | Injury, poisoning and procedural complications | Systematic Assessment | Discomfort on finger from pulse oximeter |
|
| Somnolence (sleepiness) | Nervous system disorders | Systematic Assessment |
|
| Chest discomfort (twinge following inhalation) | Cardiac disorders | Systematic Assessment |
|
| Increase in blood pressure prior inhalation | Vascular disorders | Systematic Assessment |
|
| Back pain from lying in scanner | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |