CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
GE-141, Hyperpolarized 129Xenon gas +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03078192
NCT03078192Phase 2Completed

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

Bastiaan Driehuys·interventional·Posted Mar 13, 2017·Updated Feb 22, 2022

In Brief

A Phase 2 clinical trial evaluating GE-141, Hyperpolarized 129Xenon gas and MRI for Pulmonary Vascular Disease. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 13, 2017
Enrollment StartMay 3, 2017
Primary CompletionOct 22, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.3 years ago

Interventions

GE-141, Hyperpolarized 129Xenon gasdrug

XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe

MRIdevice

Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon