Comparison of 133Xe Scintigraphy With 19F MRI
Withdrawn before enrolling · Early Phase 1
Conditions studied: Lung Diseases
In brief
The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy
Key facts
- Study ID
- NCT03532334
- Run by
- Hal C Charles
- People needed
- 0
- Starts
- 2018-04-04
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2018-07-24
Who can join
Age: 18 and older, up to 99. 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
- 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 urine pregnancy test. This will be confirmed before participation in this investigational protocol.
- Completion of 133Xe ventilation scintigraphy after referral for ventilation imaging for any reason in Pro00081987 A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy. The MRI will be accomplished in a timely fashion after the Scintigraphy study based on scheduling availability in the Center for Advanced Magnetic Resonance Development (CAMRD).
You may not qualify if…
- Subjects presenting with any of the following will not be included in the trial:
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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