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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
Must not have
Subject is less than 18 years old
Subject has any form of known cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I have not smoked in the last 5 years.
Select...
I do not have any lung conditions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I have a known heart condition.
Select...
I am currently taking beta blockers.
Select...
I had a PET scan less than a week before my xenon MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brow adipose tissue volume
Secondary study objectives
Change in BAT temperature
Side effects data
From 2012 Phase 3 trial • 600 Patients • NCT011204058%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2080
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
59 Previous Clinical Trials
4,426 Total Patients Enrolled
1 Trials studying Obesity
40 Patients Enrolled for Obesity
University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,537 Total Patients Enrolled
65 Trials studying Obesity
58,412 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have not had a lung infection within the last 15 days.I have not taken any experimental drugs within 30 days before my MRI, except for 129Xe.I have a known heart condition.I am currently taking beta blockers.I had a PET scan less than a week before my xenon MRI.I am healthy and may or may not have had a PET scan.I can follow the study's requirements or have someone who can help me do so.I am 18 years old or older.I have not smoked in the last 5 years.I do not have any lung conditions.I am 18 years old or older.I am willing to participate in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Xenon inhalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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