NCT03331302

Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.

Detailed description

Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure. The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial. The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard). In this study we will test the imaging parameters and techniques. We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI. Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Hyperpolarized Xenon-129 MRI (Experimental)	MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
DRUG	Radioactive Xenon-133 scintigraphy (Active Comparator)	Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-06-30
• Completion: 2020-12-31
• First posted: 2017-11-06
• Last updated: 2020-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study