Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT02976935
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02976935
Study Brief:
Protocol Section:
NCT02976935