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NCT05433961 · ClinicalTrials.gov registry record · Phase 1
Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI
A Phase 1 study, sponsored by Xemed.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT05433961: Clinical Trial Phase 1 study, sponsored by Xemed.
NCT05433961 is a Phase 1 study that was terminated before completion, run by Xemed. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05433961, a Phase 1 study, was terminated before completion, sponsored by Xemed.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial valve (EBV) therapy as part of their clinical standard-of-care. Once inhaled, HP xenon can provide information to imagers regarding functionality across specific regions of the lungs through the assessment of the replacement of air during the normal breathing cycle, how much oxygen is in the airspaces, and if the normal spongy tissue structure has been compromised by lung disease. Pre- (baseline) and post-EBV (follow-up) lung function imaging with HPXe will potentially lead to be better understand disease progression and treatment mechanism.
Primary Outcome
Endobronchial valve receiving patients will have HPXe MRI sessions for assessing lung function parameters as measured from inhaled hyperpolarized xenon distribution inside the lungs. Fractional ventilation will be obtained based on the signal build up for dynamic breathing of HP 129Xe and room air. TV and FRC will be determined based on the signal build up at inhalation and the gas remaining in the lung at exhalation. τ will be determined by the signal intensity reaching other parts of the lung
Interventions
- DRUG MagniXene Hyperpolarized Xenon MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2023-10-20 |
| Est. Completion | 2025-09-11 |
| Phase | Phase 1 |
Why NCT05433961 stopped before completion
NCT05433961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which MagniXene Hyperpolarized Xenon MRI is the first listed.
NCT05433961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05433961 about?
NCT05433961 is a clinical study titled "Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI". This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial valve (EBV) therapy as part of their clinical standard-of-care. Once inhaled, HP xenon can provide information to imagers regarding functionalit...
What is the current status of trial NCT05433961?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2023-10-20. Estimated completion is 2025-09-11.
What interventions are being tested in trial NCT05433961?
The interventions under investigation include: MagniXene Hyperpolarized Xenon MRI (DRUG).
Who is sponsoring clinical trial NCT05433961?
This trial is sponsored by Xemed, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05433961's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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