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Gas

Xenon MRI for Detecting Brown Fat in Obesity

Phase 1
Recruiting
Led By Rosa Tamara Branca, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has not smoked in the previous 5 years
Subject has no diagnosed pulmonary condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

Study Summary

This trial will help assess whether or not xenon MRI is a feasible method for detecting brown adipose tissue.

Who is the study for?
This study is for healthy adults over 18 who haven't smoked in the last 5 years and have no lung conditions or history of significant smoking. Participants must be able to hold their breath for at least 15 seconds, not be pregnant or breastfeeding, free from severe claustrophobia, and without any metal implants that could interfere with MRI.Check my eligibility
What is being tested?
The trial is testing if a special type of MRI using hyperpolarized xenon gas can effectively visualize brown fat tissue in the body under normal and slightly cold conditions. It aims to assess image quality and detect activity within this fat tissue.See study design
What are the potential side effects?
There may be minimal side effects since the intervention involves inhaling xenon gas for imaging purposes. However, participants might experience discomfort from holding their breath during MRI scans or mild anxiety due to being in a confined space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not smoked in the last 5 years.
Select...
I do not have any lung conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brow adipose tissue volume
Secondary outcome measures
Change in BAT temperature

Side effects data

From 2012 Phase 3 trial • 600 Patients • NCT01120405
8%
Procedural Pain
7%
Hypertension
6%
Hyperthermia
5%
Pain
5%
Procedural Hypertension
4%
Procedural Nausea
3%
Procedural Vomiting
1%
Post Procedural Haemorrhage
1%
Post Procedural Haematoma
1%
Ischaemic Stroke
1%
Hypoxia
1%
Cardio-respiratory arrest
1%
Myocardial Infarction
1%
Troponin Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sevoflurane
Xenon

Trial Design

1Treatment groups
Experimental Treatment
Group I: Xenon inhalationExperimental Treatment1 Intervention
Inhalation of 5 doses of 750ml of hyperpolarized 129Xe gas
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xenon
2011
Completed Phase 4
~2040

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

North Carolina Translational and Clinical Sciences InstituteOTHER
56 Previous Clinical Trials
4,271 Total Patients Enrolled
1 Trials studying Obesity
40 Patients Enrolled for Obesity
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,002 Total Patients Enrolled
64 Trials studying Obesity
58,022 Patients Enrolled for Obesity
Rosa Tamara Branca, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Obesity
40 Patients Enrolled for Obesity

Media Library

Xenon (Gas) Clinical Trial Eligibility Overview. Trial Name: NCT02220426 — Phase 1
Obesity Research Study Groups: Xenon inhalation
Obesity Clinical Trial 2023: Xenon Highlights & Side Effects. Trial Name: NCT02220426 — Phase 1
Xenon (Gas) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02220426 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment size for this trial?

"Yes, research hosted on clinicaltrials.gov reveals that this experiment is now recruiting participants. This trial was initially publicized on September 1st 2015 and recently updated June 9th 2022; it is aiming to recruit 24 individuals from a single site."

Answered by AI

Are individuals of forty years or greater potentially eligible for enrollment in this investigation?

"According to the study entry requisites, only individuals aged 18 - 60 can participate in this clinical trial. Alternatively, there are 207 trials open for those under 18 and 607 studies available for seniors over 65 years of age."

Answered by AI

To what extent has this treatment been tested in prior clinical experiments?

"Currently, 15 medical studies are looking into this treatment with none of them in Phase 3. Even though a majority of these experiments take place in Philadelphia, Pennsylvania, there are 21 locations worldwide conducting research on the intervention."

Answered by AI

What deleterious effects can this treatment have on individuals?

"The limited data available for this product indicates that it is likely to be only minimally safe, thus earning a score of 1."

Answered by AI

Is the enrollment period still open for this clinical trial?

"Per clinicaltrials.gov, this scientific investigation is still recruiting participants - the trial was first established on September 1st 2015 and its details were most recently revised on June 9th 2022."

Answered by AI

Could you elucidate the requirements for participation in this trial?

"This research is looking for 24 individuals aged 18-60 years old that are obese, non-smokers (5 pack year maximum), and possess the capacity to follow through with the study’s requirements. Furthermore, they should have no diagnosed respiratory issues."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Biomedical Research Imaging Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been diagnosed with CFS/ME by Dr. Charles Lapp, Hunter Hopkins Center and am interested in the brown as to how it might affect my energy. I am also obese so this could be twofold.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Hyperpolarized Xenon-129 Magnetic Resonance Imaging and Spectroscopy of Brown Fat: Healthy Adult Volunteer Pilot Study
2015. "Hyperpolarized Xenon-129 Magnetic Resonance Imaging and Spectroscopy of Brown Fat: Healthy Adult Volunteer Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02220426.
All > Health > Obesity
~2 spots leftby Jan 2025
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