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HP 129Xe MRI for Lung Transplant Rejection
Phase 2
Recruiting
Led By Giles Santyr, PhD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial uses MRI to study how well lungs work after a transplant.
Who is the study for?
This trial is for stable adult lung transplant recipients at UHN Toronto Lung Transplant Program. It includes those diagnosed with CLAD and those without it after a year of follow-up, provided they have an FEV1 over 1.0 L and are double lung transplant recipients. Exclusions apply to pregnant women, individuals unable to travel for MRI scans, or with conditions that prevent MRI use.Check my eligibility
What is being tested?
The study tests the use of hyperpolarized 129Xe MRI in detecting changes in the lungs of patients who have received transplants. The goal is to see if this imaging method can effectively identify structural and functional changes associated with lung transplant rejection (CLAD).See study design
What are the potential side effects?
Since the intervention involves only an imaging procedure using hyperpolarized xenon gas during an MRI scan, side effects may be minimal but could include discomfort from lying still during the scan or mild anxiety due to claustrophobia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
129Xe-MRI
Secondary outcome measures
1H-MRI
Side effects data
From 2020 Phase 3 trial • 38 Patients • NCT034176877%
Pruritus
7%
Hematemesis
7%
Hypoaesthesia oral
7%
Hair disorder
7%
Erythema
7%
Intestinal pseudo-obstruction
7%
Lacrimation increased
7%
Colitis
7%
Nausea
7%
Eye pruritus
7%
Restlessness
7%
Skin discolouration
100%
80%
60%
40%
20%
0%
Study treatment Arm
129Xe Before 133Xe
133Xe Before 129Xe
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Participants will inhale hyperpolarized 129Xe gas.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoOTHER
1,483 Previous Clinical Trials
486,402 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
692 Previous Clinical Trials
6,946,585 Total Patients Enrolled
Giles Santyr, PhDPrincipal InvestigatorThe Hospital for Sick Children
6 Previous Clinical Trials
198 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot travel to get an MRI scan.I need extra oxygen.I have received a double lung transplant.I am 18 or older and considered stable by the TLTP lung transplant team.I had a lung transplant over a year ago and my lung function hasn't significantly worsened.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
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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