CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Hyperpolarized 129Xenon gasdrug
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/NCT03367312
NCT03367312Phase 2Completed

Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI

Bastiaan Driehuys·interventional·Posted Dec 8, 2017·Updated Oct 18, 2023

In Brief

A Phase 2 clinical trial evaluating Hyperpolarized 129Xenon gas for Pulmonary Vascular Disease. Completed, enrolled 11 participants across 1 site.

Detailed Summary

This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI techniques 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 too test gas exchange dynamics with high temporal resolution. The conventional 1H MRi scans will include a free-breathing ultra-short echo time scan that provides images similar to that of a CT scan. This will be done pre, immediately post, and 2-4 hours post inhaled prostacyclin therapy.

Study Details

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

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 8, 2017
Enrollment StartMar 29, 2018
Primary CompletionOct 31, 2022
Study CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 8.6 years ago

Interventions

Hyperpolarized 129Xenon gasdrug

Hyperpolarized 129Xenon gas XeMRI scans will provide 3D images of ventilation and gas exchange pre, post, and 2-4 hours post inhaled prostacyclin treatment. Subjects will inhale HP 129Xe from the dose delivery bags with each scan and then move into the scanner and undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will undergo several MRI scans after inhalation of HPXe. This will occur as three scans at the three different time points (pre, post, and 2-4 hours post) of inhaled prostacyclin treatment.