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NCT03078192 · ClinicalTrials.gov registry record · Phase 2

Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging

A Phase 2 study, sponsored by Bastiaan Driehuys.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target

NCT03078192: Completed Phase 2 study, sponsored by Bastiaan Driehuys.

NCT03078192 is a Phase 2 study that has completed, run by Bastiaan Driehuys. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03078192, a Phase 2 study, has completed, sponsored by Bastiaan Driehuys.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target

Study Summary

This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI technqiues for imaging lung structure and perfusion. Specifically, the 129Xe MRI scans will provide 3D images of ventilation and gas exchange, and spectroscopic indices will be evaluated to test gas exchange dynamics with high temporal resolution. The conventional 1H MRI scans will include a free-breathing ultra-short echo time (UTE) scan that provides images similar to that of a CT scan. In addition, to characterize perfusion and vascular dimensions directly, patients will undergo a gadolinium-enhanced perfusion scan.

Primary Outcome

Determine diagnostic accuracy of XeMRI compared to the gold standard of hemodynamic and clinical criteria of pulmonary arterial hypertension (Hemodynamic criteria: mean pulmonary artery pressure \> 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg, and pulmonary vascular resistance ≥ 3 Wood units; Clinical criteria: absence of significant systolic dysfunction (LVEF \> 40%) or valvular heart disease (moderate or greater mitral or aortic valve disease); absence of significant obstructive or res

Interventions

  • DEVICE MRI
  • DRUG GE-141, Hyperpolarized 129Xenon gas

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2017-05-03
Est. Completion 2020-10-22
Phase Phase 2
Bastiaan Driehuys

16 total trials

What the finished NCT03078192 record still lists

NCT03078192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 2 interventions - of which MRI is the first listed.

NCT03078192 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03078192 about?

NCT03078192 is a clinical study titled "Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging". This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI technqiues for imaging lung structure and perfusion. Specifically, the 129Xe MRI scans will provide 3D images of ventilation and gas exchange, and spectroscopic indices will be evaluated to tes...

What is the current status of trial NCT03078192?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2017-05-03. Estimated completion is 2020-10-22.

What interventions are being tested in trial NCT03078192?

The interventions under investigation include: MRI (DEVICE), GE-141, Hyperpolarized 129Xenon gas (DRUG).

Who is sponsoring clinical trial NCT03078192?

This trial is sponsored by Bastiaan Driehuys, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03078192's enrollment target sits among peer trials

62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03078192, the US trial registry maintained by the National Library of Medicine. NCT03078192 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.