Ignite Creation Date:
2024-05-06 @ 2:22 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02024737
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2013-12-27
Brief Title:
SILO2 Signal Intensity Lung washOut
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SILO2
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 additionhow 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
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 additionhow 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None