Imaging Regional Lung Defect Severity
Completed · Phase 1/Phase 2
Conditions studied: COPD
In brief
The purpose of this study is to develop and evaluate the usefulness of magnetic resonance imaging (MRI) using inert perfluorinated gases mixed with oxygen for regional assessment of pulmonary function. The proposed study seeks to determine regional qualitative and quantitative lung function information in the context of the clinical trajectory of chronic obstructive pulmonary disease (COPD) defined by the cross sectional cohort component. In the case of these perfluorinated (PFx)/oxygen mixtures, the availability of multi-liter quantities allows for wash-in/wash-out image acquisition and analysis allowing direct measures of gas trapping in a manner not easily achieved with any existing modality.
Key facts
- Study ID
- NCT01640288
- Run by
- Hal C Charles
- People needed
- 171
- Starts
- 2013-01-01
- Expected to finish
- 2018-08-10
- Last updated by the study team
- 2020-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
- Abuse of alcohol or illicit substances
- Medical conditions, which, in the opinion of the investigator, will significantly affect five-year survival.
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine, renal insufficiency with epidermal growth factor receptor (eGFR) < 60 mL/min/1.73 m2)
- Continued therapy with the patient's prescribed COPD regimen will be permitted. Similarly, all other prescribed medications will be allowed.
- Normal Subjects: All subjects will be adults (age >18) with normal pulmonary function tests (spirometrically confirmed) recruited from the greater Durham, North Carolina community. We anticipate 52% female and 14% minority based on community demographics (see below). No subject will be excluded from the study on the basis of gender or ethnicity. Female subjects of childbearing potential will undergo pregnancy testing at study entry, and before each procedure. Informed consent will be obtained before a subject begins any study.
- Inclusion criteria,
- Outpatients of either gender, age > 18.
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
- Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.
- Normal pulmonary function testing (PFT) determined by spirometry.
- Exclusion criteria
- Abuse of alcohol or illicit substances
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
Where it is running
- Duke Image Analysis Laboratory — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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