Using Xe MRI to Guide Radiation Therapy for Lung Cancer ((XeRTLC))

Image-Based Functionally Adapted 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, and to guide radiation therapy away from parts of the lung that have good function. This project is foundational to performing additional studies to establish if novel MRI imaging can serve as a guidance tool for lung cancer radiation treatment.

Study Overview

• Status: Recruiting
• Conditions: Imaging Techniques
• Intervention / Treatment: Drug: Xenon MRI; Diagnostic test: Pulmonary Function Testing; Other: Quality of Life Questionnaire; Other: Medical Research Council Dyspnea score; Other: St. George's Respiratory Questionnaire; Diagnostic test: Blood Biomarkers

Detailed Description

Despite the recent implementation of daily adaptation of image-guided radiation treatment using highly precise beam delivery technologies, significant acute and chronic lung toxicity is still reported in approximately 20% of lung cancer patients undergoing radiation therapy. Furthermore, subclinical loss of lung function is a concern for long term outcomes and quality of life. The purpose of this pilot study is to develop, implement and evaluate the efficacy of a new radiation therapy (RT) treatment planning paradigm that incorporates regional pulmonary functional imaging information to reduce radiation dose to healthy lung tissues.

The central hypothesis is that functional lung magnetic resonance imaging (MRI) using hyperpolarized xenon (Xe) will provide the means to visualize and quantify acute ventilation and gas exchange alterations during a standard course of RT treatment, and that modifying radiation treatment plans based on the combination of functional and anatomical MRI will result in improved outcomes for lung cancer patients in the short and long term. The rationale for the proposed research is that the implementation of functional imaging context into RT treatment planning is currently inhibited by a lack of access to routine MRI-guidance and a robust workflow to practically incorporate functional information into clinical treatment planning.

The study has the following Specific Aims: 1) Develop automated software tools to integrate functional Xe MRI into RT treatment planning software and establish a comprehensive clinical workflow to reduce radiation dose in highly-functioning regions of the lung, 2) Monitor the acute and chronic effects of RT on lung ventilation and gas exchange using Xe MRI and identify early functional imaging biomarkers of radiation induced lung injury, and 3) Compare outcomes and the post-treatment trajectory of pulmonary functional measurements between functional MRI-guided and standard RT cohorts to assess the potential efficacy of Xe MRI guided adaptive RT. The overall scientific objective is to develop a comprehensive workflow that enables functional lung sparing and monitoring of acute and chronic (6 months post RT) pulmonary functional injury in lung cancer patients.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eric Bruening; Phone Number: 319 678 238 319-789-0806; Email: eric-bruening@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Eric Bruening; Phone Number: 319 678 2385; Email: eric-bruening@uiowa.edu
      • Principal Investigator: Sean Fain, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial

1. Aged 18-80 years
2. Willing and able to provide informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
3. Clinical diagnosis of lung cancer made by a board-certified oncologist with intent to treat with stereotactic body radiation therapy. We will not exclude individuals based on cancer type or severity of disease with the exception of the below criteria

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial:

1. Subject is less than 18 years old or incarcerated
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Resting oxygen saturation <90% on supplemental oxygen
5. Respiratory illness of bacterial or viral etiology within 30 days of planned treatment
6. Subject has history of any known ventricular cardiac arrhythmia
7. Subject has history of cardiac arrest within the last year
8. Subject has prior history of cancer treatment with radiation therapy to the lung
9. Subject has concurrent cancer treatment with agents associated with increased risk of radiation pneumonitis (e.g. immunotherapy, chemotherapy)
10. Subject does not fit into 129Xe vest coil used for MRI
11. Subject cannot hold his/her breath for 15 seconds
12. Subject deemed unlikely to be able to comply with instructions during imaging
13. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technical Development Arm; Lung cancer patients who will undergo standard-of-care stereotactic body radiation therapy (SBRT).	Drug: Xenon MRI; MRI with Xenon used for contrast; Diagnostic test: Pulmonary Function Testing; Pulmonary function testing will include spirometry, lung volumes, DLCO and oscillometry; Other: Quality of Life Questionnaire; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30+QLQ-LC29); Other: Medical Research Council Dyspnea score; modified Medical Research Council Dyspnea score (mMRC Dyspnea); Other: St. George's Respiratory Questionnaire; St. George's Respiratory Questionnaire (SGRQ); Diagnostic test: Blood Biomarkers; blood biomarkers of inflammation and injury (e.g. Angiopoetin-2, Interleukin-6, myofibroblast activity, BPD4)
Experimental: Implementation Arm; Lung cancer patients who will undergo SBRT plans that were functionally adapted to avoid highly functioning lung based on Xe MRI.	Drug: Xenon MRI; MRI with Xenon used for contrast; Diagnostic test: Pulmonary Function Testing; Pulmonary function testing will include spirometry, lung volumes, DLCO and oscillometry; Other: Quality of Life Questionnaire; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30+QLQ-LC29); Other: Medical Research Council Dyspnea score; modified Medical Research Council Dyspnea score (mMRC Dyspnea); Other: St. George's Respiratory Questionnaire; St. George's Respiratory Questionnaire (SGRQ); Diagnostic test: Blood Biomarkers; blood biomarkers of inflammation and injury (e.g. Angiopoetin-2, Interleukin-6, myofibroblast activity, BPD4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of PFT evidence of radiation pneumonitis and lung function change on spirometry	is the incidence of PFT evidence of radiation pneumonitis and lung function change. Change in spirometry will be reported as the mean±SD of these measurements for each treatment study visit, and the mean difference of these measurements from baseline.	Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit..

Collaborators and Investigators

• Sponsor: Sean Fain
• Investigators: Principal Investigator: Sean Fain, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Imaging; Lung cancer; Xenon
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Respiratory Function Tests
• Other Study ID Numbers: 202408283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No