Study of Airflow in the Lungs Using Helium MRI (NCT02154568) | Clinical Trial Compass
CompletedNot Applicable
Study of Airflow in the Lungs Using Helium MRI
United States24 participantsStarted 2013-11-07
Plain-language summary
Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy subjects:
* Normal PFT values: FEV1 \> 90% predicted; and Forced vital capacity (FVC) \> 90% predicted
* Normal chest x-ray (CXR)
* Medical history: No active pulmonary symptoms (cough, shortness of breath, sputum); Negative history of pulmonary disease; Negative smoking history (never smoked)
* Pulmonary Disease Subjects:
* PFT values: FEV1/FVC \< 70% (indicative of obstruction); and 30% \< FEV1 \< 50% predicted
* CXR normal except hyperinflation
* Symptoms - chronic shortness of breath
* All test subjects, healthy and with COPD should have similar physical anthropometric characteristics:
* Similar age with age difference less than 3 years
* Similar height (within 3-4 inches)
Exclusion Criteria:
* Any condition for which a MRI procedure is contraindicated.
* Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
* Likelihood of claustrophobia
* Chest circumference greater than that of the helium MR coil.
* Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.