Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02220426
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2014-08-15
Brief Title:
Hyperpolarized Xenon-129 Magnetic Resonance Imaging and Spectroscopy of Brown Fat Healthy Adult Volunteer Pilot Study
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None