Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05433961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-11
First Post:
2022-06-22
Brief Title:
Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI
Sponsor:
Xemed LLC
Organization:
Xemed LLC
Study Overview
Official Title:
Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging MRI to study lung function of COPD patients who will receive endobronchial valve EBV therapy as part of their clinical standard-of-care Once inhaled HP xenon can provide information to imagers regarding functionality across specific regions of the lungs through the assessment of the replacement of air during the normal breathing cycle how much oxygen is in the airspaces and if the normal spongy tissue structure has been compromised by lung disease Pre- baseline and post-EBV follow-up lung function imaging with HPXe will potentially lead to be better understand disease progression and treatment mechanism
Detailed Description:
This study will be assessing the pulmonary function of COPD patients receiving endobronchial valve EBV therapy as part of their clinical care by using HP 129Xe MRI in an effort to evaluate the imaging techniques performance in identifying abnormal lung function and micromorphology in patients receiving this therapy HP Xe MRI study visits will last 1-2 hours for each subject with the possibility of multiple follow-ups in longitudinal studies The investigators plan to recruit volunteer patients who are scheduled to receive EBV therapy for the treatment of COPD as part of their clinical standard-of-care Patients will be imaged at at least two time point pre-EBV baseline and 45 days post-EBV follow-up
Subjects will provide a brief medical history and perform pulmonary function testing PFT prior to inhalation of HP xenon-129 If a subject has performed a PFT at the Hospital of the University of Pennsylvania or Temple University Hospital within one month of the study visit and the results are accessible by the research team subjects will not be required to repeat PFTs for the purpose of imaging
During a typical HXe MRI session subjects will first be imaged using standard 1H MRI to generate an anatomical reference image This will be followed by the inhalation of a small amount 200 ml of HP 129Xe from a Tedlar bag to perform a frequency calibration as well as determine the effective flip-angle to be used for the subject Finally the subject will sequentially inhale up to 50 breaths of hyperpolarized 129Xe from a gas mixing apparatus designed to oxygenate and dilute the gas maintaining near normoxic conditions and approximately 10 xenon concentration During this period the lungs will be continuously imaged using a 3D sequence and a very low flip-angle 3 degrees pulse The subject will be coached to maintain a reasonably steady breathing cadence of 10-15 breaths per minute depending on their size and natural breathing rate but will be otherwise unconstrained with respect to breath timing and volume
Subjects will provide a brief medical history and perform pulmonary function testing PFT prior to inhalation of HP xenon-129 If a subject has performed a PFT at the Hospital of the University of Pennsylvania or Temple University Hospital within one month of the study visit and the results are accessible by the research team subjects will not be required to repeat PFTs for the purpose of imaging
During a typical HXe MRI session subjects will first be imaged using standard 1H MRI to generate an anatomical reference image This will be followed by the inhalation of a small amount 200 ml of HP 129Xe from a Tedlar bag to perform a frequency calibration as well as determine the effective flip-angle to be used for the subject Finally the subject will sequentially inhale up to 50 breaths of hyperpolarized 129Xe from a gas mixing apparatus designed to oxygenate and dilute the gas maintaining near normoxic conditions and approximately 10 xenon concentration During this period the lungs will be continuously imaged using a 3D sequence and a very low flip-angle 3 degrees pulse The subject will be coached to maintain a reasonably steady breathing cadence of 10-15 breaths per minute depending on their size and natural breathing rate but will be otherwise unconstrained with respect to breath timing and volume
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