Clinical trial

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

Name
14-1211
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.
Trial arms
Trial start
2015-09-01
Estimated PCD
2025-01-01
Trial end
2025-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Xenon
Inhalation of hyperpolarized xenon gas
Arms:
Xenon inhalation
Other names:
Hyperpolarized xenon gas
Size
32
Primary endpoint
Brow adipose tissue volume
Day 1
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}
Updated at
2023-07-27

1 organization

1 product

1 indication

Product
Xenon
Indication
Obesity