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

NCT05816616 | Withdrawn FDA Drug

• 1 other identifier: 851758
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COPD

Keywords

hyperpolarized xenon-129 MRI; COPD; Targeted Lung Denervation (TLD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

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

Interventions

Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRI DIAGNOSTIC_TEST

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.

COPD-TLD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be selected from the pool of patients with severe COPD enrolled in Targeted Lung Denervation therapy AIFLOW-3 clinical trial ongoing at Temple University Hospital.

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: collaborator
• Xemed LLC: lead
• University of Pennsylvania: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 18, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: January 20, 2026

Record last verified: 2025-01