Post Single or Double Lung Transplant Clinical Trial
— DIAL1001005Official title:
Evaluation of Regional Lung Function in Lung Transplant Recipients Using 19F Magnetic Resonance Imaging of Inert Perfluorinated Gases Mixed With Oxygen
Verified date | November 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | August 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Hal C Charles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | obtain regional, non-invasive images of pulmonary function in patient's post lung transplantation | 1 day (Single exposure) | No |