Hyperpolarized Xenon MRI for Chronic Obstructive Pulmonary Disease
Recruiting in Palo Alto (17 mi)
Overseen byKevin Ma, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Xemed LLC
Disqualifiers: Pregnancy, Metal implants, Organ failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment MagniXene Hyperpolarized Xenon MRI for Chronic Obstructive Pulmonary Disease?
Research shows that hyperpolarized xenon-129 MRI is a promising tool for assessing lung function in COPD, providing detailed images of how well the lungs are working. This imaging method has been shown to help understand changes in lung physiology and can be more effective than other imaging techniques in evaluating lung conditions.
12345Is hyperpolarized xenon MRI safe for humans?
Studies show that hyperpolarized xenon MRI is generally safe for humans, including those with lung diseases, when inhaling controlled amounts of the gas and holding their breath for short periods. Continuous monitoring during the procedure is important to ensure safety.
36789How does hyperpolarized xenon MRI differ from other treatments for COPD?
Hyperpolarized xenon MRI is unique because it uses a special form of xenon gas to create detailed images of the lungs, helping to assess lung function and structure in COPD patients. Unlike traditional treatments that focus on relieving symptoms, this imaging technique provides a non-invasive way to understand the disease's impact on lung function and can help track the effectiveness of other therapies.
1231011Eligibility Criteria
This trial is for COPD patients who are scheduled to receive endobronchial valve therapy. Participants must be alert, cooperative, and willing to return for all scheduled visits and tests.Inclusion Criteria
Patient is conscious, cooperative and agrees to return for scheduled visits and tests
I have COPD and am scheduled for valve therapy.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Imaging
Participants undergo baseline imaging with hyperpolarized xenon-129 MRI prior to receiving endobronchial valve therapy
1-2 hours
1 visit (in-person)
Post-EBV Imaging
Participants undergo follow-up imaging with hyperpolarized xenon-129 MRI approximately 45 days after receiving endobronchial valve therapy
1-2 hours
1 visit (in-person)
Follow-up
Participants are monitored for lung function changes and safety after treatment
90 days
Participant Groups
The study is testing the use of a special type of lung imaging called hyperpolarized xenon-129 MRI on COPD patients before and after they get endobronchial valve therapy. This aims to better understand lung function changes due to treatment.
1Treatment groups
Experimental Treatment
Group I: Hyperpolarized Xenon MRI assessment of lung function in endobronchial valve treated COPD patientsExperimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hospital of the University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Xemed LLCLead Sponsor
University of PennsylvaniaCollaborator
References
Treatment response of ethyl pyruvate in a mouse model of chronic obstructive pulmonary disease studied by hyperpolarized 129 Xe MRI. [2018]Label="PURPOSE">The purpose of this work was to investigate disease progression and treatment response in a murine model of chronic obstructive pulmonary disease (COPD) using a preclinical hyperpolarized 129 Xe (HPXe) magnetic resonance imaging (MRI) strategy.
Probing Changes in Lung Physiology in COPD Using CT, Perfusion MRI, and Hyperpolarized Xenon-129 MRI. [2020]Chronic obstructive pulmonary disease (COPD) is highly heterogeneous and not well understood. Hyperpolarized xenon-129 (Xe129) magnetic resonance imaging (MRI) provides a unique way to assess important lung functions such as gas uptake. In this pilot study, we exploited multiple imaging modalities, including computed tomography (CT), gadolinium-enhanced perfusion MRI, and Xe129 MRI, to perform a detailed investigation of changes in lung morphology and functions in COPD. Utility and strengths of Xe129 MRI in assessing COPD were also evaluated against the other imaging modalities.
Large production system for hyperpolarized 129Xe for human lung imaging studies. [2022]Hyperpolarized gases such as (129)Xe and (3)He have high potential as imaging agents for functional lung magnetic resonance imaging (MRI). We present new technology offering (129)Xe production rates with order-of-magnitude improvement over existing systems, to liter per hour at 50% polarization. Human lung imaging studies with xenon, initially limited by the modest quantity and quality of hyperpolarized gas available, can now be performed with multiliter quantities several times daily.
Delayed ventilation assessment using fast dynamic hyperpolarised Xenon-129 magnetic resonance imaging. [2023]Label="OBJECTIVES" NlmCategory="OBJECTIVE">To investigate the use of a fast dynamic hyperpolarised 129Xe ventilation magnetic resonance imaging (DXeV-MRI) method for detecting and quantifying delayed ventilation in patients with chronic obstructive pulmonary disease (COPD).
Hyperpolarized gas MRI in pulmonology. [2020]Lung diseases have a high prevalence amongst the world population and their early diagnosis has been pointed out to be key for successful treatment. However, there is still a lack of non-invasive examination methods with sensitivity to early, local deterioration of lung function. Proton-based lung MRI is particularly challenging due to short T2* times and low proton density within the lung tissue. Hyperpolarized gas MRI is aan emerging technology providing a richness of methodologies which overcome the aforementioned problems. Unlike proton-based MRI, lung MRI of hyperpolarized gases may rely on imaging of spins in the lung's gas spaces or inside the lung tissue and thereby add substantial value and diagnostic potential to lung MRI. This review article gives an introduction to the MR physics of hyperpolarized media and presents the current state of hyperpolarized gas MRI of 3Headvasd and 129Xe in pulmonology. Key applications, ranging from static and dynamic ventilation imaging as well as oxygen-pressure mapping to 129Xe dissolved-phase imaging and spectroscopy are presented. Hyperpolarized gas MRI is compared to alternative examination methods based on MRI and future directions of hyperpolarized gas MRI are discussed.
Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]The invention of hyperpolarized (HP) noble gas MRI using helium-3 ((3)He) or xenon-129 ((129)Xe) has provided a new method to evaluate lung function. Using HP (3)He or (129)Xe for inhalation into the lung air spaces as an MRI contrast agent significantly increases MR signal and makes pulmonary ventilation imaging feasible. This review focuses on important aspects of pulmonary HP noble gas MRI, including the following: (1) functional imaging types, (2) applications for major pulmonary diseases, (3) safety considerations, and (4) future directions. Although it is still challenging to use pulmonary HP noble gas MRI clinically, the technology offers promise for the investigation of the microstructure and function of the lungs.
Physiological response of rats to delivery of helium and xenon: implications for hyperpolarized noble gas imaging. [2019]The physiological effects of various hyperpolarized helium and xenon MRI-compatible breathing protocols were investigated in 17 Sprague-Dawley rats, by continuous monitoring of blood oxygen saturation, heart rate, EKG, temperature and endotracheal pressure. The protocols included alternating breaths of pure noble gas and oxygen, continuous breaths of pure noble gas, breath-holds of pure noble gas for varying durations, and helium breath-holds preceded by two helium rinses. Alternate-breath protocols up to 128 breaths caused a decrease in oxygen saturation level of less than 5% for either helium or xenon, whereas 16 continuous-breaths caused a 31.5% +/- 2.3% decrease in oxygen saturation for helium and a 30.7% +/- 1. 3% decrease for xenon. Breath-hold protocols up to 25 s did not cause the oxygen saturation to fall below 90% for either of the noble gases. Oxygen saturation values below 90% are considered pathological. At 30 s of breath-hold, the blood oxygen saturation dropped precipitously to 82% +/- 0.6% for helium, and to 76.5% +/- 7. 4% for xenon. Breath-holds longer than 10 s preceded by pre-rinses caused oxygen saturation to drop below 90%. These findings demonstrate the need for standardized noble gas inhalation procedures that have been carefully tested, and for continuous physiological monitoring to ensure the safety of the subject. We find short breath-hold and alternate-breath protocols to be safe procedures for use in hyperpolarized noble gas MRI experiments.
Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. [2022]The objective of this study was to evaluate the tolerability of hyperpolarized (129)Xe gas inhaled from functional residual capacity and magnetic resonance imaging in healthy subjects and those with pulmonary disease.
Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. [2022]To evaluate the safety and tolerability of inhaling multiple 1-L volumes of undiluted hyperpolarized xenon 129 ((129)Xe) followed by up to a 16-second breath hold and magnetic resonance (MR) imaging.
[Magnetic resonance tomography with inhalation of polarized noble gases: new perspectives in functional imaging diagnosis of emphysema]. [2015]Based on a review of the background of MRI using inhaled hyperpolarized noble gases first experiences and perspectives for functional imaging in emphysema patients are presented.
Development of hyperpolarized noble gas MRI. [2019]Magnetic resonance imaging using the MR signal from hyperpolarized noble gases 129Xe and 3He may become an important new diagnostic technique. Alex Pines (adapting the hyperpolarization technique pioneered by William Happer) presented MR spectroscopy studies using hyperpolarized 129Xe. The current authors recognized that the enormous enhancement in the delectability of 129Xe, promised by hyperpolarization, would solve the daunting SNR problems impeding their attempts to use 129Xe as an in vivo MR probe, especially in order to study the action of general anesthetics. It was hoped that hyperpolarized 129Xe MRI would yield resolutions equivalent to that achievable with conventional 1H2O MRI, and that xenon's solubility in lipids would facilitate investigations of lipid-rich tissues that had as yet been hard to image. The publication of hyperpolarized 129Xe images of excised mouse lungs heralded the emergence of hyperpolarized noble-gas MRI. Using hyperpolarized 3He, researchers have obtained images of the lung gas space of guinea pigs and of humans. Lung gas images from patients with pulmonary disease have recently been reported. 3He is easier to hyperpolarize than 129Xe, and it yields a stronger MR signal, but its extremely low solubility in blood precludes its use for the imaging of tissue. Xenon, however, readily dissolves in blood, and the T1, of dissolved 129Xe is long enough for sufficient polarization to be carried by the circulation to distal tissues. Hyperpolarized 129Xe dissolved-phase tissue spectra from the thorax and head of rodents and humans have been obtained, as have chemical shift 129 Xe images from the head of rats. Lung gas 129Xe images of rodents, and more recently of humans, have been reported. Hyperpolarized 129Xe MRI (HypX-MRI) may elucidate the link between the structure of the lung and its function. The technique may also be useful in identifying ventilation-perfusion mismatch in patients with pulmonary embolism, in staging and tracking the success of therapeutic approaches in patients with chronic obstructive airway diseases, and in identifying candidates for lung transplantation or reduction surgery. The high lipophilicity of xenon may allow MR investigations of the integrity and function of excitable lipid membranes. Eventually, HypX-MRI may permit better imaging of the lipid-rich structures of the brain. Cortical brain function is one perfusion-dependent phenomena that may be explored with hyperpolarized 129Xe MR. This leads to the exciting possibility of conducting hyperpolarized 129Xe functional MRI (HypX-fMRI) studies.