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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Brow Adipose Tissue Surface Area
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Xenon inhalation
Inhalation up to 5 doses of 750ml of hyperpolarized 129Xe gas
干预措施: Xenon (Drug)
结局指标
主要结局
Brow Adipose Tissue Surface Area
时间窗: 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.
次要结局
- Change in BAT Temperature(Day 1)