Xenon-129 MRI for Pulmonary Disease
Palo Alto (17 mi)Overseen byGiles Santyr, PhD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: The Hospital for Sick Children
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Aim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.
Is the treatment Xenon-129 MRI a promising treatment for lung disease?Yes, Xenon-129 MRI is a promising treatment for lung disease. It offers a new way to see how well the lungs are working by showing both air flow and gas exchange. This can help doctors better understand and manage lung conditions, including lung cancer. The technology has improved, making it more available for use in hospitals, and it provides unique insights into lung function that other methods can't offer.13478
What safety data exists for Xenon-129 MRI for pulmonary disease?The provided research does not contain specific safety data for Xenon-129 MRI or related terms like Hyperpolarized Xenon-129. The studies focus on gadolinium-based contrast agents used in MRI, which are different from Xenon-129. Therefore, no relevant safety data for Xenon-129 MRI is available in the provided research.2691011
Do I need to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, it requires that participants with CF and asthma are at their baseline level of symptom control, which might imply continuing current treatments. Please consult with the trial investigators for specific guidance.
What data supports the idea that Xenon-129 MRI for Pulmonary Disease is an effective treatment?The available research shows that Xenon-129 MRI is a promising tool for assessing lung function, particularly in conditions like pulmonary fibrosis. It allows for detailed imaging of lung ventilation and gas exchange, which can help detect impaired lung physiology. This method is well-tolerated by both healthy individuals and those with lung diseases, making it a viable option for evaluating lung health. While the studies focus on its use as an imaging tool rather than a direct treatment, the ability to accurately assess lung function can aid in better management of pulmonary diseases compared to traditional methods.3451213
Eligibility Criteria
This trial is for healthy individuals and those with cystic fibrosis or asthma, aged 8 and older, who have never smoked and can hold their breath for at least 16 seconds. Participants must be able to perform consistent pulmonary function tests and not require supplemental oxygen. Those with severe heart conditions, mental incapacitation, recent respiratory infections, claustrophobia that prevents MRI scans, pregnancy or metal implants incompatible with MRI are excluded.Treatment Details
The study is testing the quality of lung images taken using Xenon-129 and Perfluoropropane (19F) gases in an MRI scan. It aims to compare these images between healthy volunteers and patients with cystic fibrosis or asthma to detect changes in lung structure and function.
3Treatment groups
Active Control
Group I: HealthyActive Control3 Interventions
Healthy Participants ages 8 and older. Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.
Group II: Cystic FibrisosActive Control3 Interventions
Participants with cystic fibrosis ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.
Group III: AsthmaActive Control3 Interventions
Participants with asthma ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.
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Research locations nearbySelect from list below to view details:
The Hospital for Sick ChildrenToronto, Canada
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
References
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.
Acute adverse reactions to magnetic resonance contrast media--gadolinium chelates. [2013]The objective of this study was to evaluate the clinical safety of intravenous gadolinium-based contrast media used in patients who underwent MRI at a single institution. Acute adverse reactions to intravenous gadolinium-based contrast media used for MRI at the Princess Margaret Hospital, Hong Kong, SAR, from January 1999 to November 2004 were recorded in an incidence log book. The medical records of patients' demographics were retrospectively reviewed and the nature, frequency and severity of the adverse reactions were investigated and documented. The incidence of acute adverse reactions to intravenous gadolinium-based contrast media was 0.48% (45 patients with 46 adverse reactions). The severity of these adverse reactions were 96% mild, 2% moderate (one patient developed shortness of breath that required oxygen supplementation and intravenous steroidal management) and 2% severe (one patient developed an anaphylactoid reaction, but successfully recovered through timely resuscitation). No patients were recorded as having contrast extravasation and none died as a result of any adverse reaction. Among the 45 patients who developed adverse reactions, three patients (6.7%) had prior adverse reactions to iodinated contrast media, three (6.7%) had prior reactions to a different gadolinium-based contrast agent, one (2%) had asthma and nine (20%) had a history of drug/food allergy. Overall, 41% of the adverse reactions were not documented in the final MRI report or the clinical medical records. Gadolinium-based contrast media are safe and well tolerated by the vast majority of patients. In our study, the adverse reaction rate (0.48%) and the incidence of severe anaphylactoid reaction (0.01%) concur with those reported in the literature. Although most of the symptoms are mild and transient, these adverse reactions must be accurately documented and managed.
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.
Pulmonary perfusion and xenon gas exchange in rats: MR imaging with intravenous injection of hyperpolarized 129Xe. [2021]To develop and demonstrate a method for regional evaluation of pulmonary perfusion and gas exchange based on intravenous injection of hyperpolarized xenon 129 ((129)Xe) and subsequent magnetic resonance (MR) imaging of the gas-phase (129)Xe emerging in the alveolar airspaces.
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.
Acute side effects of three commonly used gadolinium contrast agents in the paediatric population. [2018]To determine the incidence of acute side effects of three commonly used gadolinium contrast agents in the paediatric population.
The role of hyperpolarized 129xenon in MR imaging of pulmonary function. [2018]In the last two decades, functional imaging of the lungs using hyperpolarized noble gases has entered the clinical stage. Both helium (3He) and xenon (129Xe) gas have been thoroughly investigated for their ability to assess both the global and regional patterns of lung ventilation. With advances in polarizer technology and the current transition towards the widely available 129Xe gas, this method is ready for translation to the clinic. Currently, hyperpolarized (HP) noble gas lung MRI is limited to selected academic institutions; yet, the promising results from initial clinical trials have drawn the attention of the pulmonary medicine community. HP 129Xe MRI provides not only 3-dimensional ventilation imaging, but also unique capabilities for probing regional lung physiology. In this review article, we aim to (1) provide a brief overview of current ventilation MR imaging techniques, (2) emphasize the role of HP 129Xe MRI within the array of different imaging strategies, (3) discuss the unique imaging possibilities with HP 129Xe MRI, and (4) propose clinical applications.
Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is an emerging imaging modality that allows assessment of both ventilation and gas transfer. Most research to date has focused on non-malignant pulmonary diseases. However, the capability of evaluating the two primary physiological processes of the lung (ventilation and gas transfer) makes HP 129 Xe MRI a promising imaging modality in the management of patients with lung cancer.
Gadobutrol: A Review in Contrast-Enhanced MRI and MRA. [2022]Intravenous gadobutrol [Gadovist™ (EU); Gadavist® (USA)] is a second-generation, extracellular non-ionic macrocyclic gadolinium-based contrast agent (GBCA) that is approved for use in paediatric (including term neonates) and adult patients undergoing diagnostic contrast-enhanced (CE) MRI for visualization of pathological lesions in all body regions or for CE MRA to evaluate perfusion and flow-related abnormalities. Its unique physicochemical profile, including its high thermostability and proton relaxation times, means that gadobutrol is formulated at twice the gadolinium ion concentration of other GBCAs, resulting in a narrower bolus and consequently, improved dynamic image enhancement. Based on >  20 years of experience in the clinical trial and real-world settings (>  50 million doses) and its low risk for developing nephrogenic systemic fibrosis (NSF), gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related abnormalities in all body regions in a broad spectrum of patients, including term neonates and other paediatric patients, young and elderly adult patients, and those with moderate or severe renal or hepatic impairment or cardiovascular (CV) disease.
Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]Gadolinium-based contrast agents (GBCAs) have been used to improve image quality of MRI examinations for decades and have an excellent overall safety record. However, there are well-documented risks associated with GBCAs and our understanding and management of these risks continue to evolve. The purpose of this review is to discuss the safety of GBCAs used in MRI in adult and pediatric populations. We focus particular attention on acute adverse reactions, nephrogenic systemic fibrosis and gadolinium deposition. We also discuss the non-GBCA MRI contrast agent ferumoxytol, which is increasing in use and has its own risk profile. Finally, we identify special populations at higher risk of harm from GBCA administration.
Pharmacokinetics, Safety, and Efficacy of Gadopiclenol in Pediatric Patients Aged 2 to 17 Years. [2023]The aim of this study was to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of gadopiclenol, a new high-relaxivity gadolinium-based contrast agent, in children aged 2 to 17 years.
Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary Physiology in Patients with Pulmonary Fibrosis. [2023]Label="PURPOSE" NlmCategory="OBJECTIVE">The existing tools to quantify lung function in interstitial lung diseases have significant limitations. Lung MRI imaging using inhaled hyperpolarized xenon-129 gas (129Xe) as a contrast agent is a new technology for measuring regional lung physiology. We sought to assess the utility of the 129Xe MRI in detecting impaired lung physiology in usual interstitial pneumonia (UIP).
Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. [2023]Hyperpolarized 129Xe MRI comprises a unique array of structural and functional lung imaging techniques. Technique standardization across sites is increasingly important given the recent FDA approval of 129Xe as an MR contrast agent and as interest in 129Xe MRI increases among research and clinical institutions. Members of the 129Xe MRI Clinical Trials Consortium (Xe MRI CTC) have agreed upon best practices for each of the key aspects of the 129Xe MRI workflow, and these recommendations are summarized in a recent publication. This work provides practical information to develop an end-to-end workflow for collecting 129Xe MR images of lung ventilation according to the Xe MRI CTC recommendations. Preparation and administration of 129Xe for MR studies will be discussed and demonstrated, with specific topics including choice of appropriate gas volumes for entire studies and for individual MR scans, preparation and delivery of individual 129Xe doses, and best practices for monitoring subject safety and 129Xe tolerability during studies. Key MR technical considerations will also be covered, including pulse sequence types and optimized parameters, calibration of 129Xe flip angle and center frequency, and 129Xe MRI ventilation image analysis.