Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI

NCT05433961 | Terminated Phase 1 FDA Drug

• 1 other identifier: 8511358
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

endobroncial valve; hyperpolarized xenon; lung MRI

Outcome Measures

Primary Outcomes (1)

• Lung function changes from baseline (pre) to follow-up (post) EBV procedure as measured with hyperpolarized xenon MRI.

  Endobronchial valve receiving patients will have HPXe MRI sessions for assessing lung function parameters as measured from inhaled hyperpolarized xenon distribution inside the lungs. Fractional ventilation will be obtained based on the signal build up for dynamic breathing of HP 129Xe and room air. TV and FRC will be determined based on the signal build up at inhalation and the gas remaining in the lung at exhalation. τ will be determined by the signal intensity reaching other parts of the lung relative to the signal intensity in the trachea. ADC will be determined using diffusion sensitizing gradients according to standard imaging protocols. Additionally, dissolved phase MR imaging of HP 129Xe will be assessed in order to obtain information regarding microstructural abnormalities that affect gas uptake into the blood. All these parameters are mapped as 3D lung images, and they will be compared between baseline and follow-up session.

  90 days

Study Arms (1)

Hyperpolarized Xenon MRI assessment of lung function in endobronchial valve treated COPD patients

EXPERIMENTAL

Volunteer patients scheduled for receiving endobronchial valve treatment as part of clinical care will be imaged with hyperpolarized xenon prior and post EBV for assessing lung function and improvement.

Drug: MagniXene Hyperpolarized Xenon MRI

Interventions

MagniXene Hyperpolarized Xenon MRI DRUG

Magnetic Resonance Imaging of lung function using Hyperpolarized Xenon as a contrast agent.

Hyperpolarized Xenon MRI assessment of lung function in endobronchial valve treated COPD patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients scheduled to receive endobronchial valve therapy
• Patient is conscious, cooperative and agrees to return for scheduled visits and tests

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 weighting more than 300 pounds.
• Subjects with chest size larger than the bore of MRI machine from the study.

Sponsors & Collaborators

• Xemed LLC: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin Ma, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: October 20, 2023
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)