Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04071769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2019-08-09
Brief Title:
Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Using Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary Fibrosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is being done to determine whether magnetic resonance imaging MRI using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis IPF patients receiving approved IPF treatments
Subjects will undergo an approximately hour long comprehensive MRI protocol including administration of multiple doses of hyper-polarized 129 Xenon The subjects will have this initial study prior to initiation of IPF therapies Then the subjects will have repeat studies at 3 6 and 12 months following the initiation of therapy Additional studies including pulmonary function studies serum for bio markers 6 minute walk distance and a high-resolution computed tomography HRCT scan only at the 6 month visit will be performed to determine how 129 Xenon MRI performs relative to standard of care evaluations for IPF
The MRI uses a magnet and radio waves to make diagnostic medical images of the body There have been no ill effects reported from exposure to the magnetism or radio waves used in this test Risks of the xenon gas are slight numbness in legs nausea a feeling of well-being and mild tingling in fingertips You will have pulmonary function testing for the study you may experience breathlessness or dizziness during or immediately following these tests
Subjects will undergo an approximately hour long comprehensive MRI protocol including administration of multiple doses of hyper-polarized 129 Xenon The subjects will have this initial study prior to initiation of IPF therapies Then the subjects will have repeat studies at 3 6 and 12 months following the initiation of therapy Additional studies including pulmonary function studies serum for bio markers 6 minute walk distance and a high-resolution computed tomography HRCT scan only at the 6 month visit will be performed to determine how 129 Xenon MRI performs relative to standard of care evaluations for IPF
The MRI uses a magnet and radio waves to make diagnostic medical images of the body There have been no ill effects reported from exposure to the magnetism or radio waves used in this test Risks of the xenon gas are slight numbness in legs nausea a feeling of well-being and mild tingling in fingertips You will have pulmonary function testing for the study you may experience breathlessness or dizziness during or immediately following these tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None