TERMINATED

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

Conditions

Obesity Brown adipose tissue Hyperpolarized xenon gas MRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2015-09-01

Study Completion:2016-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT02220426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 -Positron Emission Tomography (PET) scan	* 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

Inclusion Criteria

Exclusion 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 -Positron Emission Tomography (PET) scan

* 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

Contacts and Locations

Principal Investigator

Rosa Tamara Branca, PhD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

Biomedical Research Imaging Center

Chapel Hill, North Carolina, 27599-7513

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Rosa Tamara Branca, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-09-01

Study Completion Date2016-07-01

Study Record Updates

Study Start Date2015-09-01

Study Completion Date2016-07-01

Terms related to this study

Keywords Provided by Researchers

Brown adipose tissue
Hyperpolarized xenon gas MRI

Additional Relevant MeSH Terms

Obesity