Functional magnetic resonance lung imaging using inhaled hyperpolarised 129Xeno

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease; Respiratory

• Registration Number: ISRCTN56900576
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-17
• Study Completion: 2021-12-31
• Last Update Posted: 17 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Current participant inclusion criteria as of 22/12/2022:
General inclusion criteria:
1. Aged 18 years or over
2. Capacity to give informed consent
3. Normal blood pressure (systolic BP > 100 mmHg and diastolic BP > 70 mmHg)
4. Resting heart rate > 50 bpm
5. For women, negative urinary ß-hCG at the screening and subsequent visits
6. Subject able to hold breath for 10 seconds
7. Subject able to fit into 129Xe chest coil used for MRI
8. Subject able to understand the requirements of the study and to cooperate with the study procedures

Healthy volunteer inclusion criteria:
No significant respiratory disease within the last year

COPD patient inclusion criteria:
1. Evidence of airflow obstruction (FEV/FVC <0.7) and FEV1 <80% predicted post bronchodilator
2. Minimum FVC 1.5L

Previous participant inclusion criteria:
General inclusion criteria:
1. Aged 18 years or over
2. Capacity to give informed consent
3. Normal blood pressure (systolic BP > 100 mmHg and diastolic BP > 70 mmHg)
4. Resting heart rate > 50 bpm
5. For women, negative urinary ß-hCG at the screening and subsequent visits
6. Subject able to hold breath for 10 seconds
7. Subject able to fit into 129Xe chest coil used for MRI
8. Subject able to understand the requirements of the study and to cooperate with the study procedures

Healthy volunteer inclusion criteria:
No significant respiratory disease within the last year

COPD patient inclusion criteria:
1. Evidence of airflow obstruction (FEV/FVC <0.7) and FEV1 <80% predicted post bronchodilator
2. Minimum FVC 1.5L

IPF patient inclusion criteria:
1. Diagnosis of IPF by high resolution CT scan
2. Full pulmonary function test performed within 12 months prior to imaging
3. Minimum FVC 1.5

Exclusion Criteria

Healthy volunteer exclusion criteria:
1. Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
2. Acute respiratory illness within 30 days of MRI
3. 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
4. Subject deemed unlikely to comply with instructions during imaging
5. Do not meet the inclusion criteria above
6. Subject not deemed fit enough to tolerate procedure
7. Subject deemed unsuitable by clinical investigator for other reasons

COPD and IPD patient exclusion criteria:
1. Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
2. Acute respiratory illness within 30 days of MRI
3. 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
4. Subject deemed unlikely to comply with instructions during imaging
5. Do not meet the inclusion criteria above
6. Subject not deemed fit enough to tolerate procedure
7. Subject deemed unsuitable by clinical investigator for other reasons

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pattern of spontaneously resolving ventilation defects measured using 129Xe MRI lung imaging completed over a 4-week period<br>2. Estimates of lung volumes measured using 129Xe MRI lung imaging completed over a 4-week period

Secondary Outcome Measures

Name	Time	Method
1. Compare 129Xe MRI-obtained lung function parameters with matched clinical data e.g. (pulmonary function tests) over a 4-week period, allowing comparison with existing clinical diagnostic techniques and determining correlation with disease severity<br>2. Use the images obtained to set up standard sequencing protocols and define algorithms and inform power calculations for subsequent studies<br>3. Safety data measured using study records before and after 129Xe inhalation