Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2014-02-28
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Volunteers
Subjects will receive 1L non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath while the MRI scan is performed. Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2:Identical to Study Visit 1 but with the further series of inhalations being up to a maximum of 4 (maximum total exposure to hyperpolarised 129Xenon will be 5L).Optional Study Visit #3: Identical to Study Visit 2 (maximum total exposure to hyperpolarised 129Xenon will be 5L)
hyperpolarised 129 Xenon
Hyperpolarised 129 Xe to assess lung function
Chronic Obstructive Pulmonary Disease
Subjects will receive 1L bag of non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath for required time while the MRI scan is performed.Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2: Identical to Study Visit 1 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L)
hyperpolarised 129 Xenon
Hyperpolarised 129 Xe to assess lung function
Interventions
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hyperpolarised 129 Xenon
Hyperpolarised 129 Xe to assess lung function
Eligibility Criteria
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Inclusion Criteria
* 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
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
* 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
* Subject not deemed fit enough to tolerate procedure
* Subject deemed unsuitable by clinical investigator for other reasons
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Locations
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Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham
Nottingham, , United Kingdom
Countries
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Other Identifiers
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13104
Identifier Type: -
Identifier Source: org_study_id