What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy. Surgery can lead to complications such as infections and respiratory issues. Radiation therapy often causes fatigue, skin changes, and lung inflammation. Chemotherapy side effects include nausea, vomiting, hair loss, and increased risk of infections. Targeted therapies, which attack specific cancer cells, can cause skin problems, diarrhea, and liver issues. Immunotherapy, which boosts the immune system to fight cancer, may result in fatigue, skin rashes, and autoimmune reactions. Treatments similar to those studied with Hyperpolarized Xenon-129 MRI, such as advanced imaging techniques, primarily aim to improve treatment precision and reduce side effects by preserving healthy lung tissue.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). These include targeted therapies such as afatinib, which is used for EGFR-positive NSCLC, and immunotherapies like atezolizumab and cemiplimab, which target PD-L1. These treatments aim to improve overall survival and progression-free survival in patients. While Hyperpolarized Xenon-129 MRI is an investigational approach focusing on lung function, the approved therapies primarily target genetic mutations and immune checkpoints to manage NSCLC.

What other types of research exist?

Promising novel alternatives to Hyperpolarized Xenon-129 MRI for NSCLC patients include 18F-Fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET) and integrated PET/MRI. These modalities provide detailed metabolic and anatomical information, which can be crucial for accurate diagnosis, staging, and treatment planning.

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Radiation Therapy

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

Phase 1

Recruiting

Research Sponsored by Xemed LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients over 18 years with a diagnosis of non-small lung cancer and planned for a definitive course of radiation therapy

Be older than 18 years old

Must not have

Patients less than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year.

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced imaging to help treat lung cancer patients. It aims to protect healthy lung tissue while effectively targeting the tumor.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort from lying still during the MRI scan, anxiety due to claustrophobia inside the machine (if pre-existing), and very rare reactions related to inhaling hyperpolarized xenon gas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and diagnosed with non-small lung cancer, scheduled for radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients reporting one or more adverse events related to hyperpolarized xenon inhalation in this population.

Secondary study objectives

Number of patients with radiation therapy related adverse events as assessed by CTCAE v4.0.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis.Experimental Treatment1 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 Treatment1 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy. Surgery removes the tumor, radiation therapy uses high-energy rays to kill cancer cells, chemotherapy employs drugs to target rapidly dividing cells, targeted therapy blocks specific molecules involved in cancer growth, and immunotherapy enhances the immune system's ability to fight cancer. Hyperpolarized Xenon-129 MRI, which provides detailed maps of lung ventilatory function and gas exchange, is crucial for planning and monitoring these treatments. It helps identify the functional status of different lung regions, optimizing therapeutic outcomes and minimizing damage to healthy lung tissue.

Reversible ventilation and perfusion abnormalities in unilateral obstructed lung.Magnetic resonance imaging of the time course of hyperpolarized 129Xe gas exchange in the human lungs and heart.Investigating lung responses with functional hyperpolarized xenon-129 MRI in an ex vivo rat model of asthma.