Comparison of 133Xe Scintigraphy With 19F MRI
Status: | Withdrawn |
---|---|
Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 7/26/2018 |
Start Date: | April 4, 2018 |
End Date: | December 2019 |
Comparison of 133Xe Scintigraphy With 19F MRI for Evaluation of Lung Ventilation Function: A Non-Inferiority Comparison (DIAL1001007)
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
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
Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy
with performance using 19F Perfluorinated gas MRI using two independent readers.
133Xe Scintigraphy will be scored using the methods described in the statistics section and
19F images will be scored using the methods described in the statistics section. Scores for
each subject will be earluated for consistency between readers and modalities. 60%
concordance will be considered equivalent.
The outcomes of the work proposed is expected to show the non-inferiority of 19F
Perfluorinated gas MRI to 133Xenon Scintigraphy
with performance using 19F Perfluorinated gas MRI using two independent readers.
133Xe Scintigraphy will be scored using the methods described in the statistics section and
19F images will be scored using the methods described in the statistics section. Scores for
each subject will be earluated for consistency between readers and modalities. 60%
concordance will be considered equivalent.
The outcomes of the work proposed is expected to show the non-inferiority of 19F
Perfluorinated gas MRI to 133Xenon Scintigraphy
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the trial
1. Outpatients of either gender, age > 18.
2. Willing and able to give informed consent and adhere to visit/protocol schedules.
(Consent must be given before any study procedures are performed.)
3. Women of childbearing potential must have a negative urine pregnancy test. This will
be confirmed before participation in this investigational protocol.
4. 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).
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the trial:
1. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to
lie supine)
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Cecil Charles, PhD
Phone: 919-684-7931
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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