Hyperpolarized Xenon Functional Lung Imaging in COPD Patients Undergoing Targeted Lung Denervation

COPD Clinical Trial

Official title:

Pilot Study of Hyperpolarized Xenon Functional Lung Imaging in COPD Patients Undergoing Targeted Lung Denervation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05816616
• Other study ID #: 851758
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2023
• Source: Xemed LLC
• Contact: Ryan Baron, PhD
• Phone: 215-662-6678
• Email: ryan.baron[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Targeted Lung Denervation (TLD) Therapy is intended to improve airway smooth muscle relaxation from the site of treatment all the way to the lung periphery, which may be beneficial in the treatment of patients with COPD. To better understand the physiological effects of this therapy, the investigators intend to conduct a functional magnetic resonance imaging study of the lung with HP 129Xe study in COPD patients undergoing this procedure. HP 129Xe provides valuable regional information about ventilation and gas exchange in both healthy and diseased lung.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Diagnostic Test:
• Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRI
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Xemed LLC	Temple University, University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in regional lung ventilation from pre-TLD baseline to three months post-TLD.	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