Advanced Imaging for Radiation Planning in Non-Small Cell Lung Cancer

Overseen By Steven Feigenberg, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Xemed LLC

Disqualifiers: Pregnancy, Implanted metal, Organ failure, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to enhance radiation treatment for individuals with non-small cell lung cancer. It employs a special type of MRI, known as hyperpolarized xenon-129 MRI, to create 3D maps of lung function. The aim is to target the cancer more precisely while safeguarding healthy lung tissue, potentially reducing side effects and improving quality of life post-treatment. The trial seeks participants with non-small cell lung cancer who are scheduled for radiation therapy, particularly those who have previously undergone successful radiation treatment or have lung conditions like severe COPD. As a Phase 1 trial, the research focuses on understanding how the treatment functions in people, offering participants the opportunity to be among the first to experience this innovative approach.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves MRI scans, you should inform the study team about all medications you are taking, as some might interact with the imaging process.

What prior data suggests that Hyperpolarized Xenon-129 MRI is safe for use in lung cancer radiation planning?

Research has shown that hyperpolarized xenon-129 MRI is generally safe for lung imaging. Studies involving patients with conditions like chronic obstructive pulmonary disease (COPD) and asthma indicate that this imaging method is well-tolerated. In one study, 11 patients with non-small cell lung cancer underwent hyperpolarized xenon-129 MRI before their radiation therapy, and researchers reported no significant side effects.

Another study confirmed that the doses of hyperpolarized xenon-129 used for imaging are safe. This finding is consistent across various studies, suggesting that the imaging process does not pose significant risks. Overall, evidence supports that hyperpolarized xenon-129 MRI is a safe option for lung imaging, making it a promising tool for enhancing radiation treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized Xenon-129 (HXe) MRI in treating non-small cell lung cancer because it offers a novel way to plan radiation therapy by mapping lung function in 3D. Unlike standard imaging methods, HXe MRI provides detailed insights into lung ventilation and function, allowing for more personalized radiation therapy plans that avoid healthy lung tissue. This approach has the potential to minimize side effects and improve overall treatment outcomes by preserving lung function, making it a promising advancement compared to traditional CT scans and MRI techniques.

What evidence suggests that Hyperpolarized Xenon-129 MRI is effective for improving radiation treatment plans in non-small cell lung cancer?

Research has shown that hyperpolarized xenon-129 MRI offers a promising new way to image the lungs. This technique enables doctors to create detailed 3D maps to assess lung function. In this trial, participants with non-small cell lung cancer will have their lung ventilation and function imaged using this method. One arm of the trial will use these images to guide standard-of-care radiation therapy, while another arm will use them to optimize radiation therapy for functional lung avoidance. This approach aims to help doctors target the tumor while sparing healthy lung tissue. Early findings suggest that this could reduce the risk of radiation pneumonitis, a condition where the lungs become inflamed after radiation therapy, and improve the quality of life for patients after treatment. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-small cell lung cancer who are set for radiation therapy. It's also open to those with severe COPD or a history of successful prior lung cancer treatment and now facing secondary lung cancer. Exclusions include pregnancy, inability to consent, unstable living situations, substance dependence, large body size or chest that won't fit in an MRI machine, metal implants, and certain health conditions.

Inclusion Criteria

I had successful radiation for lung cancer and now have a second lung cancer.

I have new lung cancer and severe COPD, and am planned for radiation therapy.

Exclusion Criteria

You have a metal device implanted in your body.

A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study

If you have any reason that makes it unsafe for you to have an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiation therapy with functional lung avoidance using hyperpolarized xenon-129 MRI

1 year

Regular visits for radiation therapy sessions and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging and lung function tests

6 months

Follow-up imaging and lung function tests at 6 months

Open-label extension (optional)

Participants may continue to be monitored for long-term safety and lung function

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Xenon-129 MRI

Trial Overview The study tests hyperpolarized xenon-129 MRI's ability to map healthy vs compromised lung tissue in patients undergoing radiation therapy for lung cancer. The goal is to tailor treatment plans that minimize damage to functioning lungs and reduce the risk of radiation pneumonitis.

How Is the Trial Designed?

Group I: Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis. Experimental Treatment 1 Intervention

Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study, where they will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. However, for this part of the study, subjects will still follow the standard-of-care radiation treatment plan. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study.

Group II: Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis. Experimental Treatment 1 Intervention

Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study. They will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. Patients will follow radiation therapy optimized for functional lung avoidance. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study.

Hyperpolarized Xenon-129 MRI is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Hyperpolarized Xenon-129 MRI for:

• Respiratory diseases including asthma, COPD, cystic fibrosis, pulmonary vascular disease, idiopathic pulmonary fibrosis, lung cancer, and lymphangioleiomyomatosis

Approved in United States as Hyperpolarized Xenon-129 MRI for:

• Clinical approval pending; potential indications include respiratory diseases such as asthma, COPD, cystic fibrosis, pulmonary vascular disease, idiopathic pulmonary fibrosis, lung cancer, and lymphangioleiomyomatosis

Who Is Running the Clinical Trial?

Xemed LLC

Lead Sponsor

Trials

8

Recruited

370+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

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]

Hyperpolarized 129Xe MRI is a new imaging technique that allows for detailed lung imaging and can also detect 129Xe in the brain, providing insights into brain parenchyma and blood vessels.

The study outlines specific protocols for using 129Xe MRI in both rodents and humans, highlighting its potential for advanced medical imaging applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. Chahal, S., Prete, BRJ., Wade, A., et al.[2019]

Hyperpolarized noble gas MRI using helium-3 or xenon-129 enhances MRI signal, making it a promising method for imaging lung function and ventilation.

While there are safety considerations and challenges in clinical application, this technology holds potential for better understanding lung microstructure and function in various pulmonary diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. Liu, Z., Araki, T., Okajima, Y., et al.[2017]

The continuous flow-type hyperpolarizing (CF-HP) system allows for effective lung imaging using hyperpolarized (129)Xe MRI at very low concentrations of xenon, minimizing the anesthetic effects and reducing xenon consumption.

Using a 70% xenon gas mixture resulted in better signal-to-noise ratios for both gas and dissolved-phase images compared to a 3% mixture, although the apparent diffusion coefficient (ADC) was higher with the 3% mixture, indicating a complex relationship between concentration and imaging quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 129 Xe MRI of the mouse lung at a low xenon concentration using a continuous flow-type hyperpolarizing system. Wakayama, T., Kitamoto, M., Ueyama, T., et al.[2015]

In a pilot study involving 10 patients with non-small cell lung cancer, using hyperpolarized xenon-129 MRI for radiotherapy planning was shown to be feasible and effective in identifying well-ventilated lung areas.

The function-based radiotherapy plan (Plan-F) significantly reduced radiation exposure to well-ventilated lung regions compared to the standard anatomic plan (Plan-A), indicating a potential strategy to minimize radiation-induced lung injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of function-based radiation therapy planning for lung cancer using hyperpolarized xenon-129 ventilation MRI. Ding, Y., Yang, L., Zhou, Q., et al.[2022]

Hyperpolarized (HP) noble gas MRI, particularly using 129Xe, has shown promising results in assessing lung ventilation and regional lung physiology, making it a potential game-changer in pulmonary medicine.

Despite being limited to select academic institutions currently, advancements in polarizer technology suggest that HP 129Xe MRI could soon become more widely available for clinical use, enhancing the diagnostic capabilities for lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. Ebner, L., Kammerman, J., Driehuys, B., et al.[2018]

Hyperpolarized (HP) noble gases like (3)He and (129)Xe are emerging as noninvasive contrast agents for MRI, particularly useful in diagnosing pulmonary diseases.

Recent advancements in HP (129)Xe MR measurements have enhanced our ability to study lung dysfunctions in mice, paving the way for potential applications in human diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small animal imaging with hyperpolarized 129Xe magnetic resonance. Imai, H., Kimura, A., Fujiwara, H.[2019]

Hyperpolarized 129Xe gas is safe and well-tolerated as an inhaled contrast agent for MRI in children, with no serious adverse events reported during the study involving 28 participants aged 6 to 16 years.

While some children experienced mild and temporary changes in oxygen saturation and heart rate after inhalation, these effects were consistent with expected physiological responses and resolved quickly, indicating that 129Xe MRI is feasible for assessing lung function in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. Walkup, LL., Thomen, RP., Akinyi, TG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9776850/

Targeted Imaging of Lung Cancer with Hyperpolarized ... Hyperpolarized 129Xe (HP 129Xe) MRI enables functional imaging of various lung diseases but has been scarcely applied to lung cancer imaging.

2. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryct.240562

Hyperpolarized 129 Xe MRI and Spectroscopy Hyperpolarized xenon 129 (129Xe) MRI is an emerging modality allowing three-dimensional visualization and measurement of pulmonary ventilation, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8530914/

a comparison of ventilation- and gas-exchange-guided ... Prior to receiving conventional RT for non-small cell lung cancer, eleven patients underwent hyperpolarized 129Xe gas exchange magnetic resonance imaging (MRI) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1076633221000131

Comparison of Hyperpolarized 3He and 129Xe MR ... In this study, we compared hyperpolarized 3 He and 129 Xe images from patients with cystic fibrosis using two commonly applied magnetic resonance sequences.

5. redjournal.org redjournal.org/article/S0360-3016(21)00871-3/abstract

Hyperpolarized 129 Xe Magnetic Resonance Imaging for ... Before receiving conventional RT for non-small cell lung cancer, 11 patients underwent hyperpolarized 129Xe gas exchange magnetic resonance ...

6. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220069

Lung Abnormalities Detected with Hyperpolarized 129 Xe ... Hyperpolarized xenon 129 MRI and total lung diffusion capacity for carbon monoxide demonstrate significantly impaired gas transfer in nonhospitalized ...

7. mdpi.com mdpi.com/2075-4418/15/4/474

Hyperpolarized Xenon-129 MRI: Narrative Review of ... Publications using 129XeMRI to assess clinical observations or outcomes in pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02112929

Regional Lung Imaging Using Hyperpolarized Xenon Gas Hyperpolarized xenon, in the doses given for imaging has been shown to be safe. Conventional MRI has limited use in respiratory disease, because the lung is ...