Hyperpolarized Xenon-129 Magnetic Resonance Imaging and Spectroscopy of Brown Fat: Healthy Adult Volunteer Pilot Study

NCT02220426 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 14-1211
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Brown adipose tissue; Hyperpolarized xenon gas MRI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in BAT Temperature

  Day 1

Study Arms (1)

Xenon inhalation

OTHER

Inhalation up to 5 doses of 750ml of hyperpolarized 129Xe gas

Drug: Xenon

Interventions

Xenon DRUG

Inhalation of hyperpolarized xenon gas

Also known as: Hyperpolarized xenon gas

Xenon inhalation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

Biomedical Research Imaging Center

Chapel Hill, North Carolina, 27599-7513, United States

Location

Related Publications (1)

• 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.

  PMID: 25453088 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Xenon

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Limitations and Caveats

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.

Results Point of Contact

• Title: Rosa Tamara Branca, PhD
• Organization: University of North Carolina at Chapel Hill

rtbranca@unc.edu

9199622229

Study Officials

• Rosa Tamara Branca, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 19, 2014
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)