NCT03078192: XenonMRI

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

Completed Phase 2 Results posted Last updated 22 February 2022

What this trial tests

Phase 2 trial testing GE-141, Hyperpolarized 129Xenon gas in Pulmonary Vascular Disease in 62 participants. Completed in 22 October 2020.

Timeline

3 May 2017

Primary endpoint
22 October 2020

22 October 2020

Quick facts

Lead sponsor	Bastiaan Driehuys
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	single
Primary purpose	diagnostic
Enrollment	62
Start date	3 May 2017
Primary completion	22 October 2020
Estimated completion	22 October 2020
Sites	1 location across United States

Drugs / interventions tested

• GE-141, Hyperpolarized 129Xenon gas — full drug profile →
• MRI — full drug profile →

Conditions studied

• Pulmonary Vascular Disease — all drugs for Pulmonary Vascular Disease →

Sponsor

Bastiaan Driehuys — full company profile →

Who can join

18 and older, any sex, with Pulmonary Vascular Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants Determined to be True Positives for Pulmonary Arterial Hypertension Primary · up to 2 weeks

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 restrictive lung disease; absence of hypoxemic or hypercarbic respiratory failure; absence of chronic t

By Right Heart Cath

Group	Value	95% CI
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	10
Test Set - Pulmonary Vascular Disease	15
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	10
Test Set - Pulmonary Vascular Disease	5
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	0
Test Set - Pulmonary Vascular Disease	3
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	0
Test Set - Pulmonary Vascular Disease	2

By Xenon MRI scan

Group	Value	95% CI
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	10
Test Set - Pulmonary Vascular Disease	18
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	10
Test Set - Pulmonary Vascular Disease	8
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	0
Test Set - Pulmonary Vascular Disease	0
Training Set - PVD, Isolated Left Heart Disease, Lung Disease	0
Test Set - Pulmonary Vascular Disease	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.