Xenon MRI for Lung Cancer

((XeRTLC) Trial)

Overseen By Natally Al Arab, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sean Fain

Must not be taking: Immunotherapy, Chemotherapy

Disqualifiers: Pregnancy, Cardiac arrhythmia, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if xenon-enhanced MRI scans can improve radiation therapy planning for lung cancer patients. By highlighting well-functioning lung areas, the scans may help direct treatment away from these regions, potentially preserving lung function. Lung cancer patients planning to undergo standard stereotactic body radiation therapy (a focused radiation treatment) are suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in lung cancer care.

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

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving cancer treatment with certain agents like immunotherapy or chemotherapy, you may not be eligible to participate.

What prior data suggests that Xenon MRI is safe for lung cancer patients?

Research has shown that Xenon MRI safely and effectively examines lung function. This imaging method assesses lung performance and gas exchange. In studies with patients who had lung diseases, Xenon MRI caused no serious side effects or harm. This makes it a promising tool for guiding lung cancer treatment without adding extra risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Xenon MRI for lung cancer treatment because it offers a new way to visualize lung function, which could lead to more precise radiation therapy. Unlike traditional imaging techniques, Xenon MRI allows doctors to see how different parts of the lung are functioning, not just what they look like. This means treatments can be adapted to avoid highly functional lung areas, potentially reducing damage to healthy tissue. By tailoring radiation plans more accurately, this approach could improve outcomes and quality of life for lung cancer patients.

What evidence suggests that xenon MRI is effective for lung cancer?

Research has shown that xenon MRI is a promising tool for assessing lung function. It is safe and effectively measures how well the lungs breathe, exchange gases, and their structure. It has been successfully used in patients with lung conditions like asthma and COPD (chronic obstructive pulmonary disease). In lung diseases, it aids in understanding the condition and monitoring treatment effectiveness. In this trial, xenon MRI will guide radiation therapy in lung cancer patients. Participants in the Technical Development Arm will undergo standard-of-care stereotactic body radiation therapy (SBRT), while those in the Implementation Arm will receive SBRT plans functionally adapted to avoid highly functioning lung areas based on xenon MRI. This approach could potentially improve treatment results for lung cancer patients. ^{3 4 6 7 8}

Who Is on the Research Team?

Sean Fain, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for individuals with a clinical diagnosis of lung cancer, intending to undergo stereotactic body radiation therapy. Participants must be able and willing to give informed consent and follow the study's schedule.

Inclusion Criteria

I meet all the required conditions for the trial enrollment.

I am willing to follow the study rules and visit schedule.

I have lung cancer and will be treated with targeted radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo stereotactic body radiation therapy (SBRT) with functional adaptation using Xe MRI to avoid highly functioning lung regions

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lung function changes and radiation pneumonitis

6 months

1 month follow-up visit, 6 month follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Xenon MRI

Trial Overview

The study is testing the use of MRI scans with xenon gas to improve imaging of lung function before and after radiation therapy. The goal is to see if this method can help avoid radiating healthy parts of the lungs.

How Is the Trial Designed?

Group I: Technical Development Arm Experimental Treatment 6 Interventions

Lung cancer patients who will undergo standard-of-care stereotactic body radiation therapy (SBRT).

Group II: Implementation Arm Experimental Treatment 6 Interventions

Lung cancer patients who will undergo SBRT plans that were functionally adapted to avoid highly functioning lung based on Xe MRI.

Who Is Running the Clinical Trial?

Sean Fain

Lead Sponsor

Trials

1

Recruited

100+

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Targeted Imaging of Lung Cancer with Hyperpolarized ...

A previous study also reported that proton contrast-enhanced MRI was able to detect lung cancers 20 weeks after urethane administration [36].

2.

pubs.rsna.org

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

Hyperpolarized 129Xe MRI and Spectroscopy

Xenon 129 MRI and MR spectroscopy are safe, sensitive, and robust tools for measuring pulmonary ventilation, gas exchange, and microstructure, ...

3.

publications.ersnet.org

publications.ersnet.org/content/erj/55/2/1901987

Pulmonary xenon-129 MRI: new opportunities to unravel ...

Xe MRI methods have an excellent safety profile in patients with respiratory disease [21, 22], including asthma [23–25], COPD [16, 26–29], cystic fibrosis [30– ...

4.

mdpi.com

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ...

This indicates that three-dimensional single-breath chemical shift imaging 129XeMRI can effectively characterize lung diseases, monitor treatment responses, and ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06925295

Using Xe MRI to Guide Radiation Therapy for Lung Cancer

The purpose of this research study is to explore using MRI scans with xenon to better image lung function, how lung function changes after radiation therapy ...

6.

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) ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2452109425000971

Functional Imaging of Changes in Lung Function Before ...

We examine and compare pulmonary MRI-based measurements longitudinally in a lung cancer patient undergoing stereotactic body RT (SBRT) treatment.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06925295

Using Xe MRI to Guide Radiation Therapy for Lung Cancer

The purpose of this research study is to explore using MRI scans with xenon to better image lung function, how lung function changes after radiation therapy ...