A Phase 2 interventional study of Xenon MRI and Pulmonary Function Testing in Imaging Techniques, sponsored by Sean Fain. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Sean Fain · Phase 2, Interventional, and Diagnostic
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Sean Fain is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the trial:
Lung cancer patients who will undergo standard-of-care stereotactic body radiation therapy (SBRT).
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
Lung cancer patients who will undergo SBRT plans that were functionally adapted to avoid highly functioning lung based on Xe MRI.
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
MRI with Xenon used for contrast
Pulmonary function testing will include spirometry, lung volumes, DLCO and oscillometry
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30+QLQ-LC29)
modified Medical Research Council Dyspnea score (mMRC Dyspnea)
St. George's Respiratory Questionnaire (SGRQ)
blood biomarkers of inflammation and injury (e.g. Angiopoetin-2, Interleukin-6, myofibroblast activity, BPD4)
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.
Time frame: Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit..
Plan to share: Undecided
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Sean Fain