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Clinical Trials/NCT02024737
NCT02024737
Completed
Not Applicable

A Pilot Study to Establish the Sensitivity of MR Imaging Markers to Changes in Regional Lung Function and Gas Washout in Patients With Mild-moderate COPD

Sheffield Teaching Hospitals NHS Foundation Trust1 site in 1 country5 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment
5
Locations
1
Primary Endpoint
Reproducibilityof 3He and 129Xe MRI lung ventilation imaging as measured by Bland-Altman statistical analysis of reproducibility
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a leading and still increasing cause of disease and death worldwide, affecting those in both developed and developing countries. This imparts a massive burden of ill health, in turn imposing huge healthcare costs to society.

For effective treatment of COPD (as opposed to providing short term relief) early disease must be targeted. The small airways of the lung (those less than 2mm) are the first affected in COPD, but current methods to assess their function are relatively insensitive. There is therefore a need for new, accurate methods for detection of small airway dysfunction with sensitivity to shortterm change and regional discrimination.

In previous studies with hyperpolarised (HP) 3He MRI in smokers with normal pirometry and patients with early stage COPD, we showed sensitivity to early changes in lung ventilation and structure. The hyperpolarised gas MRI technique is safe. In particular, the lack of ionizing radiation permits patients to be imaged on multiple occasions. This and its inherent sensitivity to regional lung ventilation and function make it an ideal imaging tool for the assessment of novel lung therapies for diseases of the small airways.

The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD.

In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed.

This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
September 2015
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of study related procedures.
  • Current or exsmokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
  • Clinical diagnosis of COPD with a post bronchodilator FEV1 30-80% of personal predicted, according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.

Exclusion Criteria

  • Patients with a contra-indication to MRI scanning: i.e. patients who are non MRI compatible (ferro-magnetic metallic implants, pacemakers) as per the MRI questionnaire used in clinical practice by the Unit of Academic Radiology, Royal Hallamshire Hospital, or who are unable to tolerate the MRI.
  • Patients with renal conditions (as described in the Gd-DTPA (Gadovist) Summary of Product Characteristics) in which administration of Gd-DTPA MR vascular contrast agent would pose a risk.
  • Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
  • long and short acting beta-2 agonists
  • sympathomimetic amines
  • lactose or any of the other excipients
  • Resting oxygen saturation of \<90% on air as determined by pulse oximetry.
  • Women of child bearing potential, not using effective methods of contraception.
  • Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
  • Inability to understand or comply with study procedures; including patients unable to use a dry powder inhaler (e.g. single dose dry powder inhaler Aerolyzer®) device.

Outcomes

Primary Outcomes

Reproducibilityof 3He and 129Xe MRI lung ventilation imaging as measured by Bland-Altman statistical analysis of reproducibility

Time Frame: 21 days

Measure of long-term reproducibility of MRI imaging

Study Sites (1)

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