- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05816616
Hyperpolarized Xenon Functional Lung Imaging in COPD Patients Undergoing Targeted Lung Denervation
Pilot Study of Hyperpolarized Xenon Functional Lung Imaging in COPD Patients Undergoing Targeted Lung Denervation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be assessing the treatment response using HP 129Xe MRI for patients undergoing Target Lung Denervation (TLD) in COPD patients. Subjects eligible to participate in this study are those who agree and have already consented to participate in the AIRFLOW-3 clinical trial for TLD treatment at Temple University Hospital. The intent of this study is to image lung function using HP 129Xe MRI in ten TLD subjects before and approximately three months post TLD procedure as an observational sub-study. Subjects willing to participate in this sub-study will have to consent to this study and plan for two MRI imaging sessions: one prior TLD and a follow-up at approximately three months post TLD procedure.
As part of this companion protocol at Penn, the aim is to image each subject twice, using a total of 2.5L of HP 129Xe gas administered over approximately 50 breaths during each visit. Using the dynamic image set acquired, the investigators will characterize each imaging voxel (approximately 4mm x 4mm x 4mm) in terms of its tidal volume (in mm3), functional residual capacity (in mm3), fractional ventilation (efficiency of gas exchange via ventilation, unit less), and what is defined as "arrival time", which can be also shown as 'tidal volume hysteresis', and corresponds to the area enclosed when the local tidal volume is plotted against the inhaled gas volume. The latter parameter is zero in a region that inflates and deflates perfectly in sync with the inhaled gas volume but grows in magnitude when the two are out of sync: e.g., in cases obstructed ventilation or air trapping. 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. Each imaging session will take approximately 30 minutes, including positioning in the MRI and inhalation of a small HP 129Xe dose for scanner calibration. The proposed dynamic HP 129Xe MRI technique allows for the quantification of fractional ventilation (FV), tidal volume (TV), functional residual capacity (FRC), arrival time (τ), apparent diffusion coefficient (ADC), and dissolved phase HP 129Xe information. Obtaining all of these parameters in a single scan session reduces the necessary amount of imaging gas while increasing accuracy by correcting artifacts associated with collateral ventilation and the slow filling of parenchyma in diseased lungs. Following the two imaging sessions, data will be analyzed and compared, including comparison with other lung function measuring techniques.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ryan Baron, PhD
- Phone Number: 215-662-6678
- Email: ryan.baron@pennmedicine.upenn.edu
Study Contact Backup
- Name: Stephen Kadlecek, PhD
- Email: stephen.kadlecek@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects are already consented and enrolled in the AIRFLOW-3 clinical trial at Temple University Hospital and are willing to participate in this sub-study for assessing functional lung changes from prior to post TLD treatment using hyperpolarized xenon-129 MRI.
Exclusion Criteria:
- Patients less than 18 years old;
- Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients;
- Any known contraindication to MRI examination;
- Anyone with an implanted metal device;
- Inability to provide informed consent;
- A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study;
- History of uncompensated organ failure (i.e. organ failure that is not stabilized through medical intervention), which will be assessed by the PI;
- Homelessness or other unstable living situation;
- Active drug or alcohol dependence;
- Claustrophobia;
- Subjects with a BMI>35;
- Subjects with chest size larger than the bore of MRI machine from the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COPD-TLD patients
COPD patients to be treated with Targeted Lung Denervation and enrolled in Airflow-3 clinical trial at Temple University Hospital, and which are also willing to participate in hyperpolarized xenon imaging of their lungs prior and poste TLD treatment.
|
Patients for this observational study will be selected on a voluntarily basis from the ongoing Airflow-3 interventional clinical trial at Temple University Hospital.
For this observational sub-study, patients will have their lung function measured using hyperpolarized xenon-129 MRI prior to TLD treatment, and 90 days post-treatment for a better understanding of treatment effects.
This sub-study does not influence in any way the patient treatment or the outcomes for the main Airflow-3 TLD clinical trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in regional lung ventilation from pre-TLD baseline to three months post-TLD.
Time Frame: 3-month
|
Fractional ventilation (FV) is defined as the ratio of inspired gas to residual gas volume and it will be measured using dynamic HP 129Xe MRI performed over approximately 50 breaths during normal respiratory cycle in which small amounts of xenon will be precisely administered.
FV provides a quantitative and non-dimensional map of inhaled gas within the lungs and it is the most widely accepted quanititative measure of regional lung ventilation.
The pre and post measurements will be entered into a general linear model to search for differences.
|
3-month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 851758
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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