Imaging Lung Function Using Oxygen Enhanced MRI

Asthma Clinical Trial

Official title: A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent

Status Completed

Clinical Trial Summary

The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to allow an effect size estimate to power future studies.

Clinical Trial Description

This is an open label study expanding on work by other groups in animals, ex-vivo human lungs and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI comparing images obtained while breathing oxygen to those obtained breathing room air.

Objectives

• To determine if 1H magnetic resonance images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung functional information with oxygen as a contrast agent.

• To determine the short term reproducibility of the lung functional imaging in a subset of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1 ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• COPD
• Cystic Fibrosis
• Emphysema
• Pulmonary Disease, Chronic Obstructive
• Small Airways Disease

• NCT number: NCT01731015
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 1
• Start date: January 2012
• Completion date: September 2012