Imaging TechniquesPhase 2(XeRTLC)NCT06925295
Using Xe MRI to Guide Radiation Therapy for Lung Cancer
A Phase 2 study testing Xenon MRI, Pulmonary Function Testing and Quality of Life Questionnaire in people with Imaging Techniques, run by Sean Fain at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Imaging Techniques
- What is being tested?
- Xenon MRI, Pulmonary Function Testing and Quality of Life Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
- Aged 18-80 years
- Willing and able to provide informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
- 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
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:
- Subject is less than 18 years old or incarcerated
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Resting oxygen saturation <90% on supplemental oxygen
- Respiratory illness of bacterial or viral etiology within 30 days of planned treatment
Show all 14Show fewer
- Subject has history of any known ventricular cardiac arrhythmia
- Subject has history of cardiac arrest within the last year
- Subject has prior history of cancer treatment with radiation therapy to the lung
- Subject has concurrent cancer treatment with agents associated with increased risk of radiation pneumonitis (e.g. immunotherapy, chemotherapy)
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 15 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Eric Bruening, 319 678 2385, eric-bruening@uiowa.edu
Sean Fain, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Xenon MRI, Pulmonary Function Testing, Quality of Life Questionnaire, Medical Research Council Dyspnea score, St. George's Respiratory Questionnaire
- Keywords
- Lung cancer, Xenon, Imaging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon MRIDrug
MRI with Xenon used for contrast
Pulmonary Function TestingDiagnostic test
Pulmonary function testing will include spirometry, lung volumes, DLCO and oscillometry
Quality of Life QuestionnaireOther
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30+QLQ-LC29)
Medical Research Council Dyspnea scoreOther
modified Medical Research Council Dyspnea score (mMRC Dyspnea)
St. George's Respiratory QuestionnaireOther
St. George's Respiratory Questionnaire (SGRQ)
Blood BiomarkersDiagnostic test
blood biomarkers of inflammation and injury (e.g. Angiopoetin-2, Interleukin-6, myofibroblast activity, BPD4)
| Study group | Role | What they receive |
|---|---|---|
| Technical Development Arm | Experimental | Lung cancer patients who will undergo standard-of-care stereotactic body radiation therapy (SBRT). Receives: 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 |
| Implementation Arm | Experimental | Lung cancer patients who will undergo SBRT plans that were functionally adapted to avoid highly functioning lung based on Xe MRI. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start30 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaging TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sean Fain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sean Fain, University of Iowa
- Investigators
- Sean Fain, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925295
- Sponsor's protocol ID
- 202408283
- Acronym
- (XeRTLC)
- Status last verified
- Dec 2025
- First submitted
- 28 Mar 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Based Functionally Adapted Radiation Therapy for Lung Cancer
- ClinicalTrials.gov ID
- NCT06925295
- Acronym / sponsor ID
- (XeRTLC) / 202408283
- Conditions
- Imaging Techniques
- Keywords
- Lung cancer, Xenon, Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sean FainUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technical Development Arm | Experimental | 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 BiomarkersLung cancer patients who will undergo standard-of-care stereotactic body radiation therapy (SBRT). |
| Implementation Arm | Experimental | 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 BiomarkersLung cancer patients who will undergo SBRT plans that were functionally adapted to avoid highly functioning lung based on Xe MRI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
- Aged 18-80 years
- Willing and able to provide informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
- 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
Key exclusion criteria (14 listed)
- Subject is less than 18 years old or incarcerated
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Resting oxygen saturation <90% on supplemental oxygen
- Respiratory illness of bacterial or viral etiology within 30 days of planned treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon MRIMRI with Xenon used for contrast | Drug | Implementation Arm, Technical Development Arm |
| Pulmonary Function TestingPulmonary function testing will include spirometry, lung volumes, DLCO and oscillometry | Diagnostic test | Implementation Arm, Technical Development Arm |
| Quality of Life QuestionnaireEuropean Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30+QLQ-LC29) | Other | Implementation Arm, Technical Development Arm |
| Medical Research Council Dyspnea scoremodified Medical Research Council Dyspnea score (mMRC Dyspnea) | Other | Implementation Arm, Technical Development Arm |
| St. George's Respiratory QuestionnaireSt. George's Respiratory Questionnaire (SGRQ) | Other | Implementation Arm, Technical Development Arm |
| Blood Biomarkersblood biomarkers of inflammation and injury (e.g. Angiopoetin-2, Interleukin-6, myofibroblast activity, BPD4) | Diagnostic test | Implementation Arm, Technical Development Arm |
Primary outcome
The incidence of PFT evidence of radiation pneumonitis and lung function change on spirometry
Time frame: Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit..
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Fain, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xenon MRI, Pulmonary Function Testing and Quality of Life Questionnaire in people with Imaging Techniques, run by Sean Fain at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Bruening (319-789-0806 ext. 319 678 238, eric-bruening@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PFT evidence of radiation pneumonitis and lung function change on spirometry (time frame: Baseline Visit, periprocedural, 1 month follow up visit, and 6 month follow up visit..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.