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Hyperpolarized 129Xe MRI for Lung Disease

Phase 1
Recruiting
Led By Peter Niedbalski, PHD
Research Sponsored by Mario Castro, MD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with Lung Disease: No acute worsening of pulmonary function in the past 30 days
Healthy Volunteers: Subject has no diagnosed pulmonary conditions
Must not have
Subject cannot hold his/her breath for 15-16 seconds
Cognitive deficits that preclude ability to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if HP 129Xe gas MRI can help assess regional pulmonary function.

Who is the study for?
This trial is for healthy individuals and those with various lung diseases who can read English or Spanish. Participants must not have had a recent worsening of their condition, be able to hold their breath for about 16 seconds, and have an oxygen saturation above 88%. Pregnant or lactating individuals, those unable to fit into the MRI equipment, or with cognitive issues preventing consent are excluded.
What is being tested?
The study is testing hyperpolarized Xenon (Xe129) gas MRI as a method to evaluate lung function in both healthy people and patients with pulmonary conditions. It aims to develop this imaging technique for better assessment of regional lung function.
What are the potential side effects?
Since the intervention involves only MRI imaging using hyperpolarized Xe129 gas, side effects may include discomfort from holding one's breath during scanning and potential claustrophobia inside the MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung condition hasn't worsened in the last month.
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I do not have any lung diseases.
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I have been diagnosed with a lung condition by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot hold my breath for 15 seconds.
Select...
I am able to understand and consent to my treatment.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
RBC/Barrier Ratio
Secondary study objectives
ADC
Ventilation Defect Percentage

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: Hyperpolarized 129XeExperimental Treatment1 Intervention
Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mario Castro, MD, MPHLead Sponsor
Peter Niedbalski, PHDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
22 Total Patients Enrolled

Media Library

Hyperpolarized Xe129 Clinical Trial Eligibility Overview. Trial Name: NCT04624490 — Phase 1
Chronic Obstructive Pulmonary Disease Research Study Groups: Hyperpolarized 129Xe
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Hyperpolarized Xe129 Highlights & Side Effects. Trial Name: NCT04624490 — Phase 1
Hyperpolarized Xe129 2023 Treatment Timeline for Medical Study. Trial Name: NCT04624490 — Phase 1
~48 spots leftby Oct 2025
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