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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01280994
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria for Healthy Control Subjects
1. Subject has no diagnosed pulmonary conditions
2. Subject has not smoked in the previous 5 years.
3. Smoking history, if any, is less than or equal to 5 pack-years.
Inclusion Criteria for Subjects with lung disease
1. Subject has a diagnosis of pulmonary dysfunction made by a physician
2. No acute worsening of pulmonary function in the past 30 days
Exclusion Criteria:
1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI screening questionaire
3. Subject is pregnant or lactating
4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
5. Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
6. Subject has any form of known cardiac arrhythmia
7. Subject does not fit into 129Xe vest coil used for MRI
8. Subject cannot hold his/her breath for 15 seconds
9. Subject deemed unlikely to be able to comply with instructions during imaging
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01280994
Study Brief:
Protocol Section:
NCT01280994