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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post transplant
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had a lung transplant in the last 10 years or am being considered for one.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Capture 129Xe and proton MRI Images for clinician assessment
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
815 Previous Clinical Trials
6,531,546 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder.You feel very uncomfortable in small spaces or cannot stay still for medical scans.You are pregnant or have a positive pregnancy test.Your oxygen level is less than 95% when measured while breathing normally or while using prescribed oxygen.I have had a lung transplant in the last 10 years or am being considered for one.You can hold your breath for about 16 seconds.I have had symptoms of a respiratory infection in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Hp 129Xenon
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for enrolment in this research effort?
"Affirmative, the information found on clinicaltrials.gov implies that this experiment is actively recruiting participants. It was initially posted on September 9th 2020 and has been modified as recently as December 17th 2020. 45 individuals are needed to contribute at a single site."
Answered by AI
How many participants are currently being analyzed as part of this research endeavor?
"Affirmative. Clinicaltrials.gov data indicate that this clinical trial is presently attempting to recruit participants, which was first posted on September 9th 2020 and last edited December 17th 2020. 45 patients are required for the study at a single site."
Answered by AI
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