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NCT02478268 · ClinicalTrials.gov registry record · Phase 1
Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis
A Phase 1 study, sponsored by Bastiaan Driehuys.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT02478268: Completed Phase 1 study, sponsored by Bastiaan Driehuys.
NCT02478268 is a Phase 1 study that has completed, run by Bastiaan Driehuys. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02478268, a Phase 1 study, has completed, sponsored by Bastiaan Driehuys.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. "Investigational" means that these tests have not yet been approved by the US Food and Drug Administration and are being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational. Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.
Primary Outcome
We expect that 129Xe ventilation defect percentage, and 129Xe ventilated lung volume measured 3 months after baseline, will predict CT progression observed 12 months from baseline
Interventions
- DEVICE MRI
- DRUG Hyperpolarized 129-Xenon gas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2015-05 |
| Est. Completion | 2020-09-26 |
| Phase | Phase 1 |
What the finished NCT02478268 record still lists
NCT02478268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which MRI is the first listed.
NCT02478268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02478268 about?
NCT02478268 is a clinical study titled "Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis". The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special t...
What is the current status of trial NCT02478268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2015-05. Estimated completion is 2020-09-26.
What interventions are being tested in trial NCT02478268?
The interventions under investigation include: MRI (DEVICE), Hyperpolarized 129-Xenon gas (DRUG).
Who is sponsoring clinical trial NCT02478268?
This trial is sponsored by Bastiaan Driehuys, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02478268's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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