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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
Double lung transplant recipient
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received a double lung transplant.

Timeline

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

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 • NCT03417687
7%
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
1,468 Previous Clinical Trials
484,475 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,778 Total Patients Enrolled
Giles Santyr, PhDPrincipal InvestigatorThe Hospital for Sick Children
6 Previous Clinical Trials
198 Total Patients Enrolled

Media Library

129Xenon Clinical Trial Eligibility Overview. Trial Name: NCT05550662 — Phase 2
Lung Transplant Rejection Research Study Groups: Single arm
Lung Transplant Rejection Clinical Trial 2023: 129Xenon Highlights & Side Effects. Trial Name: NCT05550662 — Phase 2
129Xenon 2023 Treatment Timeline for Medical Study. Trial Name: NCT05550662 — Phase 2

Frequently Asked Questions

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

Does the FDA recognize 129Xenon as a valid therapeutic agent?

"Based on the available evidence, 129Xenon has been rated a two in terms of safety. As it is currently undergoing Phase 2 trials, there are limited data to support its efficacy."

Answered by AI

Is it possible for me to partake in this research project?

"This clinical trial is searching for 15 patients aged between 18 and 75 with lung transplants. To be eligible, individuals must have been declared stable by the Toronto Lung Transplant Program (TLTP), have a FEV1 level of more than 1 Litre, had no substantial and persistent decline in post-transplant follow up if they are CLAD-free or prior diagnosis of CLAD made by TLTP clinicians if not, and PFT measurements taken within one month of the scan visit."

Answered by AI

Are there any age restrictions on participation in this experiment?

"The eligibility requirements for this experiment require that the patient be aged 18 to 75. Participants younger than 18 are being recruited for two separate studies, and those over 65 can apply for one of seven different trials."

Answered by AI

Is this trial open for new participants at the present time?

"Unfortunately, according to information gathered from clinicaltrials.gov this specific medical study is not presently seeking additional participants. Initially posted on October 15th 2022, the trial was last updated on September 21st of the same year. Fortunately, there are 8 other trials which can be found that are currently enrolling eligible patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HP 129Xe MRI for Evaluation of CLAD in Lung Transplant Recipients
Giles Santyr 2024. "HP 129Xe MRI for Evaluation of CLAD in Lung Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05550662.
~9 spots leftby Oct 2024
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