Using hyperpolarized xenon MRI to detect brown fat in healthy adults

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

This study is testing if a special type of MRI using xenon gas can help see and measure brown fat in healthy adults to learn more about its role in weight and energy balance.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (other)
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT02220426 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the feasibility of detecting brown adipose tissue (BAT) in healthy adult volunteers using hyperpolarized xenon gas MRI. Participants will undergo MRI scans at 3 Tesla after inhaling hyperpolarized 129Xe gas, both at thermoneutrality and during mild cold exposure to stimulate thermogenic activity. The study will assess the image quality and the ability of xenon MRI to visualize BAT and measure its metabolic activity. The ultimate goal is to better understand the role of BAT in obesity and energy balance.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 and older with no diagnosed pulmonary conditions and a minimal smoking history.

Not a fit: Patients with contraindications to MRI, such as metal implants or severe claustrophobia, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for detecting and understanding brown fat, potentially aiding in obesity management.

How similar studies have performed: While hyperpolarized xenon MRI is established for lung studies, this specific application for detecting brown fat is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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 -PET scan

Exclusion Criteria:

* 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

Where this trial is running

Chapel Hill, North Carolina

• Biomedical Research Imaging Center — Chapel Hill, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Rosa Tamara Branca, PhD — University of North Carolina, Chapel Hill
• Study coordinator: Kristine Baluyot

Conditions: Obesity, Brown adipose tissue, Hyperpolarized xenon gas MRI