Xenon-129 MRI for Thoracic Insufficiency Syndrome

Overseen By Samantha Gogel

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Patrick Cahill, MD

Disqualifiers: Not diagnosed with TIS

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assess lung function in children with thoracic insufficiency syndrome (TIS), a condition that impairs breathing due to chest wall deformities. Researchers use a special type of MRI (Magnetic Resonance Imaging) with Xenon-129, a gas that helps create clearer lung images. The goal is to determine if this method can reliably measure lung function. Children aged 6 to 18 with TIS who plan to undergo surgery might be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance lung assessment techniques for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI technique is safe for assessing pulmonary function?

Research shows that hyperpolarized xenon-129 MRI is safe and well-tolerated for assessing lung function. This imaging method involves inhaling a special gas called xenon-129 during the MRI. The FDA has approved this technique for children aged 6 and older to evaluate lung health.

Studies have confirmed the safety of xenon-129 MRI in these children, indicating it reliably studies how air moves in and out of the lungs. No significant reports of negative effects from using xenon-129 in MRI scans have emerged, suggesting it is a low-risk option for patients needing detailed lung assessments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of Xenon-129 MRI imaging for Thoracic Insufficiency Syndrome, a method that offers a new way to assess lung function and structure. Unlike traditional imaging techniques that may not provide as detailed a view of lung ventilation, Xenon-129 MRI uses a hyperpolarized gas to produce detailed images of lung function in real-time. This can help surgeons better plan interventions by providing crucial insights into how well the lungs are working, potentially leading to more personalized and effective treatment plans.

What evidence suggests that this MRI imaging technique is effective for assessing pulmonary function in thoracic insufficiency syndrome?

Research has shown that Xenon-129 MRI, which participants in this trial will undergo, effectively checks lung function in various conditions, including those affecting children. This non-invasive method does not involve surgery or radiation. Studies have found that it provides detailed images of air movement in and out of the lungs and the efficiency of gas exchange. This is crucial for understanding complex lung issues like thoracic insufficiency syndrome, where lung function often decreases. By offering clear images of lung activity, Xenon-129 MRI can aid in assessing and potentially improving treatments for these conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrick Cahill, MD

Principal Investigator

Children's Hopsital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 6 to 18 who have been diagnosed with Thoracic Insufficiency Syndrome (TIS) and are scheduled for surgery. It's not open to those without a TIS diagnosis.

Exclusion Criteria

I do not have thoracic insufficiency syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI imaging sequences to assess pulmonary function

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI Imaging
• Xenon-129

Trial Overview

The study is testing the use of Xenon-129 in MRI imaging sequences as a new way to assess lung function in patients with TIS, which often includes chest wall deformities and spine disorders like scoliosis.

How Is the Trial Designed?

Group I: Thoracic Insufficiency Group Experimental Treatment 1 Intervention

Thoracic insufficiency syndrome patients undergoing surgery

Who Is Running the Clinical Trial?

Patrick Cahill, MD

Lead Sponsor

Trials

1

Recruited

20+

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Xemed LLC

Industry Sponsor

Trials

8

Recruited

370+

Published Research Related to This Trial

The study identifies eight key safety concerns related to clinical magnetic resonance (MR) imaging, including risks from the static magnetic field, potential projectile effects, and the impact of radio-frequency fields.

Specific issues such as noise-induced auditory effects, psychological impacts like claustrophobia, and safety considerations regarding the use of contrast agents are highlighted, emphasizing the need for awareness and management of these risks during MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations in MR imaging. Kanal, E., Shellock, FG., Talagala, L.[2013]

The recent FDA approval of hyperpolarized 129Xe as an MR contrast agent highlights its growing importance in lung imaging, prompting the need for standardized techniques across research and clinical sites.

The 129Xe MRI Clinical Trials Consortium has established best practices for the entire workflow of 129Xe MRI, including safety monitoring and technical considerations, to ensure effective and safe imaging of lung ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. Garrison, WJ., Mugler, JP., Mata, JF., et al.[2023]

Magnetic resonance imaging (MRI) using hyperpolarised gases like helium-3 and xenon-129 allows for detailed structural and functional assessments of the lungs without the risks associated with ionising radiation, making it particularly suitable for pediatric patients.

This imaging technique is crucial for understanding and treating chronic lung diseases such as asthma and cystic fibrosis, which are common in children and currently have significant unmet therapeutic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary functional magnetic resonance imaging for paediatric lung disease. Kirby, M., Coxson, HO., Parraga, G.[2013]

A new continuous-flow system for producing hyperpolarized xenon (129Xe) has been developed, achieving production rates of 0.3 liters per hour with 64% polarization, significantly improving the availability of this imaging agent for lung MRI studies.

This technology allows for the production of multiliter quantities of hyperpolarized xenon several times daily, enabling more extensive human lung imaging studies that were previously limited by the availability of hyperpolarized gas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large production system for hyperpolarized 129Xe for human lung imaging studies. Hersman, FW., Ruset, IC., Ketel, S., et al.[2022]

High-quality MRI of lung ventilation can be achieved using naturally abundant xenon (NAXe) gas, demonstrating its potential as a cost-effective imaging agent for pulmonary studies.

The study showed that NAXe MRI provided comparable image quality to enriched xenon and helium-3 (3He) imaging, with the ability to detect minor ventilation defects, particularly in a healthy smoker's lungs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of human lung ventilation imaging using highly polarized naturally abundant xenon and optimized three-dimensional steady-state free precession. Stewart, NJ., Norquay, G., Griffiths, PD., et al.[2022]

Magnetic resonance (MR) imaging is a safe diagnostic method, as it does not pose hazards to patients or medical personnel from the magnetic fields used during the procedure.

The study addresses concerns about the safety of permanent, gradient, and electromagnetic fields in MR tomography, concluding that these factors do not present significant risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety of patients and personnel at a department of MR tomography, a new method of imaging in medicine]. Gomet, B.[2015]

This case report highlights an allergic reaction to Gadolinium-DTPA, a contrast agent used in MRI scans, occurring upon the first exposure, emphasizing the need for awareness of potential allergic responses.

The report includes a review of the safety profile of MR contrast agents, suggesting that while they are generally safe, individual reactions can occur, warranting careful monitoring during their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute allergic reaction upon first exposure to gadolinium-DTPA: a case report. Rahman, SL., Harbinson, MT., Mohiaddin, R., et al.[2019]

Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is a new imaging technique that can assess both how well air moves in and out of the lungs (ventilation) and how effectively gases are transferred in the lungs.

While most studies have focused on non-cancer lung diseases, HP 129 Xe MRI shows great potential for improving the management and understanding of lung cancer by evaluating these key lung functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. Song, EJ., Kelsey, CR., Driehuys, B., et al.[2022]

The study demonstrated that injecting hyperpolarized xenon-129 (129Xe) into the bloodstream of rats is a safe method that produces a strong signal in the lungs, allowing for effective imaging of pulmonary perfusion and gas exchange.

This technique revealed important insights, such as ventilation-perfusion deficits and temporary impairments in gas exchange due to saline overload, suggesting its potential as a sensitive and non-invasive tool for evaluating lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary perfusion and xenon gas exchange in rats: MR imaging with intravenous injection of hyperpolarized 129Xe. Driehuys, B., Möller, HE., Cleveland, ZI., et al.[2021]

Over a 10-year period, the FDA received 1568 reports of adverse events related to magnetic resonance (MR) systems, with 1548 reports analyzed, highlighting the importance of monitoring safety in MR imaging.

The most common serious injuries reported were thermal events, accounting for 59% of cases, followed by mechanical events (11%), projectile events (9%), and acoustic events (6%), indicating specific risks associated with MR environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. Delfino, JG., Krainak, DM., Flesher, SA., et al.[2020]

The American College of Radiology's updated guidance document on MR safety emphasizes the importance of addressing new risks and adverse events in the MR environment, ensuring safer practices for patients and personnel.

The latest recommendations include mandatory annual MR safety training for medical directors, highlighting the need for continuous education to adapt to evolving safety concerns in clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR guidance document on MR safe practices: Updates and critical information 2019. Greenberg, TD., Hoff, MN., Gilk, TB., et al.[2021]

Hyperpolarized xenon-129 MRI detected significant lung function impairments in patients with usual interstitial pneumonia (UIP), showing a ventilation defect fraction of 30% compared to 21% in healthy controls, indicating its efficacy in identifying lung abnormalities.

The MRI also revealed elevated levels of xenon dissolved in the lung interstitium in UIP patients, which could serve as an early indicator of lung fibrosis, even when traditional pulmonary function tests showed normal or mild impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary Physiology in Patients with Pulmonary Fibrosis. Qing, K., Altes, TA., Mugler, JP., et al.[2023]

A new imaging technique allows for simultaneous acquisition of lung images using two hyperpolarized gases, helium-3 and xenon-129, along with anatomical proton images in a single breath hold, enhancing the efficiency of lung imaging.

This method provides high-quality, spatially and temporally registered images that combine functional and structural information about the lungs, which could improve diagnostic capabilities in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous imaging of lung structure and function with triple-nuclear hybrid MR imaging. Wild, JM., Marshall, H., Xu, X., et al.[2022]

Hyperpolarized 129Xe MRI (HypX-MRI) shows great promise as a new diagnostic tool, enhancing the detectability of lung structures and potentially allowing for better imaging of lipid-rich tissues, which has been challenging with traditional methods.

This technique could help identify issues like ventilation-perfusion mismatch in pulmonary diseases and may also be used for functional MRI studies of the brain, opening new avenues for understanding lung function and brain perfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. Albert, MS., Balamore, D.[2019]

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