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Hp 129Xenon Imaging for Bronchiolitis Obliterans Syndrome

Phase 1 & 2
Recruiting
Led By Jason Woods, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
Must not have
Bleeding disorders
Symptoms of respiratory infection within the past two weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new methods of imaging transplanted lungs to see if they can detect changes early on that could lead to BOS, a chronic allograft rejection.

Who is the study for?
This trial is for people who had a lung transplant within the last decade or are being evaluated for one. They must be able to hold their breath up to 16 seconds. It's not suitable for those with bleeding disorders, claustrophobia, recent respiratory infections, pregnant individuals, or anyone who can't undergo MRI scans.
What is being tested?
The study is testing Hp129 Xenon as a new imaging method aimed at early detection of Bronchiolitis Obliterans Syndrome (BOS), which affects many lung transplant recipients over time. The goal is to use these images to guide biopsies and help develop future treatments.
What are the potential side effects?
Since this trial focuses on imaging rather than medication, side effects may include discomfort from holding breath during scanning and potential risks associated with standard MRI procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a lung transplant in the last 10 years or am being considered for one.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a bleeding disorder.
Select...
I have had symptoms of a respiratory infection in the last two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Capture 129Xe and proton MRI Images for clinician assessment

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: Hp 129XenonExperimental Treatment1 Intervention
Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter.

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Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,558 Total Patients Enrolled
3 Trials studying Bronchiolitis Obliterans
2,046 Patients Enrolled for Bronchiolitis Obliterans
Jason Woods, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
8 Previous Clinical Trials
464 Total Patients Enrolled

Media Library

Hp 129Xenon Clinical Trial Eligibility Overview. Trial Name: NCT03603899 — Phase 1 & 2
Bronchiolitis Obliterans Research Study Groups: Hp 129Xenon
Bronchiolitis Obliterans Clinical Trial 2023: Hp 129Xenon Highlights & Side Effects. Trial Name: NCT03603899 — Phase 1 & 2
Hp 129Xenon 2023 Treatment Timeline for Medical Study. Trial Name: NCT03603899 — Phase 1 & 2
~18 spots leftby Oct 2027
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