NCT06925295

Using Xe MRI to Guide Radiation Therapy for Lung Cancer

Image-Based Functionally Adapted Radiation Therapy for Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Sean Fain · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Imaging Techniques

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-08-30
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-04-13
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study