MagniXene MRI Use in Patients With Asthma and COPD to Assess Regional Lung Function by Delineating Ventilation Defects — HXe-VENT  

Healthy Clinical Trial

Official title: Study of Hyperpolarized Xenon (MagniXene) in Patients With Obstructive Pulmonary Diseases (Asthma and COPD) to Assess Regional Lung Function by Delineating Regions of Abnormal Lung Ventilation

Status Completed

Clinical Trial Summary

The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.

Clinical Trial Description

HXe MRI provides a diversity of imaging techniques for interrogating pulmonary function and lung microstructure. The most mature of these techniques utilizes HXe spin-density MRI to depict regional lung ventilation. Prior work suggests that ventilation imaging has utility in all obstructive lung diseases. This is a Phase II clinical trial to assess HXe MRI capability of providing qualitative and quantitative clinical information regarding lung ventilation. Proton and xenon images will be acquired within single breath holds on 28 subjects per year, including healthy volunteers and patients with COPD and asthma. All studies will include repeat scans and Pulmonary Function Tests (PFT). Ventilation scans with Technetium-99m (Tc-99m) diethylene-triamine-pentaacetate (DTPA) aerosol scintigraphy will be acquired on lung patients.

The primary goal of this aim is to validate the effectiveness of HXe ventilation MRI for delineating regions of normal and abnormal lung ventilation. To validate the regional depiction of ventilation, HXe MRI ventilation will be compared with nuclear medicine Tc-99m DTPA ventilation scintigraphy. The comparatively low spatial and temporal resolution of ventilation scintigraphy will limit this study to demonstrating only that HXe MRI ventilation is not inferior to the current clinical standard. Additionally, the concordance between measurements of the whole lung volume from both proton MRI and HXe MRI with PFT, the current clinical standard for lung volume measurement, will be assessed as a secondary outcome of the study. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• COPD
• Healthy

• NCT number: NCT01833390
• Study type: Interventional
• Source: Xemed LLC
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Completion date: January 2015