Lung Transplant Subjects Using 19F MRI
Completed · Phase 1
Conditions studied: Post Single or Double Lung Transplant
In brief
The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gases mixed with oxygen as inhaled inert contrast agents to image the airway spaces in subjects who have undergone single or double lung transplantation. This is an open label study expanding on current work here at Duke. Images will be obtained using 19F MRI during wash-in and washout for evaluation of ventilation efficiency.
Key facts
- Study ID
- NCT02019251
- Run by
- Hal C Charles
- People needed
- 6
- Starts
- 2013-12-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2014-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Subjects must be ≥ 18 years of age;
- Post single or double lung transplant;
- Subjects who are willing and able to comply with scheduled visits and other trial procedures
You may not qualify if…
- Subjects presenting with any of the following will not be included in the trial:
- Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
- Unable to receive gas mixture by breathing because of contraindications;
- Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
- Female; women at risk of pregnancy are required to have a confirmed negative blood pregnancy test at Screening if of childbearing potential prior to the MRI scan.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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