COPD, IPF
Conditions
Brief summary
The aim of this study is to investigate the potential value of a novel imaging technique (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in patients with COPD and IPF.
Interventions
OTHERhyperpolarised 129 Xenon
Hyperpolarised 129 Xe to assess lung function
Sponsors
University of Nottingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
General Inclusion criteria * Male or Female aged over 18 years. * Capacity to give informed consent * Normal blood pressure (systolic BP \> 100 mmHg and diastolic BP \> 70 mmHg) * Resting heart rate \> 50 bpm * For women, negative urinary β-hCG at the screening and subsequent visits * Subject able to hold breath for 10 seconds * Subject able to fit into 129Xe chest coil used for MRI * Subject able to understand the requirements of the study and to cooperate with the study procedures Inclusion criteria HEALTHY VOLUNTEERS • No significant respiratory disease within the last year PATIENTS COPD * Evidence of airflow obstruction (FEV/FVC \<0.7) and FEV1 \<80% predicted post bronchodilator * Minimum FVC 1.5L
Exclusion criteria
HEALTHY VOLUNTEERS * Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire) * Acute respiratory illness within 30 days of MRI * Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study * Subject deemed unlikely to comply with instructions during imaging * Do not meet the inclusion criteria above * Subject not deemed fit enough to tolerate procedure * Subject deemed unsuitable by clinical investigator for other reasons PATIENTS * Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire) * Acute respiratory illness within 30 days of MRI * Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study * Subject deemed unlikely to comply with instructions during imaging * Do not meet the inclusion criteria above * Subject not deemed fit enough to tolerate procedure * Subject deemed unsuitable by clinical investigator for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool | 4 years | i) Obtain baseline data for each group with matched clinical data (e.g. pulmonary function tests) allowing comparison with existing clinical diagnostic techniques and also determining correlation with disease severity ii) Use the images obtained to set up standard sequencing protocols and define algorithms and inform power calculations for subsequent studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collation of data regarding ability of participants to adhere to the study protocol | 4 years | 1\) To collate data regarding the ability of participants of each group to adhere to the protocol thus informing the study design of future trials. |
Countries
United Kingdom
Outcome results
None listed