Carcinoma, Non-Small-Cell LungPhase 1/2GuidedRTNCT07355231
Lung Functional Avoidance Radiotherapy Using Hyperpolarized Xenon MRI
A Phase 1/2 study testing Hyperpolarized xenon MRI in people with Carcinoma, Non-Small-Cell Lung, run by Xemed LLC.
Trial summary
Cancer radiation treatment plans that employ lung functional avoidance methods require 3D maps that differentiate regions of healthy lung function from regions of functional compromised tissue to deliver sufficient dose to the tumor while preserving as much functioning lung as possible. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Hyperpolarized xenon MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 29 Feb 2028
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years with a diagnosis of non-small lung cancer and planned for a definitive course of radiation therapy.
- Preferred patients will have had successful radiation therapy for a prior lung cancer and developed a secondary lung cancer for which are to be treated.
- Other de-nuovo lung cancer patients planned for radiation therapy with lung heterogeneity from natural co-morbidities (e.g., COPD stage 3+).
Who cannot join
- Patients less than 18 years old
- Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients,
- Any known contraindication to MRI examination
- Anyone with an implanted metal device
- Inability to provide informed consent
- A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study.
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- History of uncompensated organ failure (i.e. organ failure that is not stabilized through medical intervention), which will be assessed by the PI.
- Homelessness or other unstable living situation
- Active drug or alcohol dependence
- Claustrophobia
- Subjects weighting more than 300 pounds.
- Subjects with chest size larger than the bore of MRI machine can accommodate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Cancer radiation treatment plans that employ lung functional avoidance methods require 3D maps that differentiate regions of healthy lung function from regions of functional compromised tissue to deliver sufficient dose to the tumor while preserving as much functioning lung as possible. Hyperpolarized xenon-129 MRI can provide maps of ventilatory function and gas exchange to the bloodstream. Improving treatment plans based on this novel imaging modality could reduce risk or severity of radiation pneumonitis and improve post-treatment quality of life.
Read the detailed description
Customized 3D planning of radiation therapy for lung cancer delivers a lethal dose to the tumor region while avoiding important structures (spine) and organs (esophagus, heart, lungs). Since radiation dose to functioning lung is associated with acute radiation pneumonitis and chronic radiation fibrosis, researchers seek to shift dosage preferentially away from lung regions with highest function. Several lung functional imaging modalities have been investigated (ventilation-perfusion SPECT and PET, 4DCT, hyperpolarized 3He). These studies indicate that regional ventilation is not the optimal biometric. What is needed is a high-resolution imaging modality, tolerable to patients who have difficulty holding their breath, that delineates regions of full lung function warranting preservation, and also identifies regions whose function is irrevocably gone.
The investigators propose a translational study applying Hyperpolarized Xenon (HXe) MRI to improve lung-health outcomes for lung cancer patients treated with radiation therapy. This study will focus on a patient cohort with significant heterogeneity: new patients with lung cancer and GOLD stage 3+ emphysema as a comorbidity and patients receiving RT for their second (primary) lung cancer. Optimizing radiation therapy treatment plans could provide a statistically significant benefit within a manageably small patient cohort. Maps will delineate three regions of functionality: regions of full function, having both ventilation and gas exchange to blood (where radiation should be avoided or minimized), regions where function is irrevocably absent (where radiation dose can be increased/maximized), and regions where function may be present or recoverable (where radiation should remain below or at the normal dose limit). Regions of lungs with absent function will have highest priority for receiving radiation during the RT procedure, while healthy regions will be avoided. It is expected that following this functional avoidance procedure will result in a decrease in the radiation induced lung injury reported events and a better outcome of the radiation treatment.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Hyperpolarized xenon MRI
- Keywords
- lung cancer, non-small-cell lung cancer, radiation therapy, guided radiation therapy, functional lung avoidance, hyperpolarized xenon, HXe MRI
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized xenon MRICombination product
Patients with non-small cell lung cancer scheduled for radiation therapy willing to take part in this study will undergo hyperpolarized xenon MRI at several time points prior and post RT. Images will be used to determine radiation treatment maps for functional lung avoidance. Reported adverse events caused by radiation induced lung injury and post-RT changes in the lung function will be compared to standard-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis. | Experimental | Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study. They will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. Patients will follow radiation therapy optimized for functional lung avoidance. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study. Receives: Combination Product: Hyperpolarized xenon MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in DLCO at 6-month post RT treatment.
Subjects will have measurements of DLCO at baseline (before RT) and at 6-month post RT. An independent-sample t-test will be used to compare change in DLCO.
Measured: 1-year
Secondary outcomes (4)
Change in Quality of Life questionnaires from baseline to 6-month post-RT.
Quality of Life questionnaires ("MD Anderson Symptom Inventory - Lung Cancer" and "UCSD Shortness of Breath Questionnaire") will be assessed at baseline (prior to RT) and 6-month post RT. A independent-sample t-test will be used to compare changes in the QoL.
Measured: 1-year
Change in HXe lung MRI metrics from baseline to 6-month post-RT.
HXe MRI metrics (including dynamic ventilation and dissolved phase - S/V and q-dot) will be assessed at baseline (prior to RT) and 6-month post RT. A independent-sample t-test will be used to compare changes in the HXe metrics.
Measured: 1-year
Change in FEV1 from baseline to 6-month post-RT.
Other spirometry measurements (besides DLCO) such as FEV1, will be assessed at baseline (prior to RT) and 6-month post RT. A independent-sample t-test will be used to compare changes in FEV1.
Measured: 1-year
Incidence/severity of pneumonitis.
Incidence/severity of pneumonitis will be graded using CTCAE at 6-month post RT. This will be compared with known results from standard-of-care RT.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Mar 2027 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1: open trial for establishing safety and methodology.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xemed LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355231
- Sponsor's protocol ID
- MagniXene-255434
- Acronym
- GuidedRT
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Functional Avoidance Radiotherapy Using Hyperpolarized Xenon MRI
- ClinicalTrials.gov ID
- NCT07355231
- Acronym / sponsor ID
- GuidedRT / MagniXene-255434
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- lung cancer, non-small-cell lung cancer, radiation therapy, guided radiation therapy, functional lung avoidance, hyperpolarized xenon, HXe MRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xemed LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
Cancer radiation treatment plans that employ lung functional avoidance methods require 3D maps that differentiate regions of healthy lung function from regions of functional compromised tissue to deliver sufficient dose to the tumor while preserving as much functioning lung as possible. Hyperpolarized xenon-129 MRI can provide maps of ventilatory function and gas exchange to the bloodstream. Improving treatment plans based on this novel imaging modality could reduce risk or severity of radiation pneumonitis and improve post-treatment quality of life.
Detailed description
Customized 3D planning of radiation therapy for lung cancer delivers a lethal dose to the tumor region while avoiding important structures (spine) and organs (esophagus, heart, lungs). Since radiation dose to functioning lung is associated with acute radiation pneumonitis and chronic radiation fibrosis, researchers seek to shift dosage preferentially away from lung regions with highest function. Several lung functional imaging modalities have been investigated (ventilation-perfusion SPECT and PET, 4DCT, hyperpolarized 3He). These studies indicate that regional ventilation is not the optimal biometric. What is needed is a high-resolution imaging modality, tolerable to patients who have difficulty holding their breath, that delineates regions of full lung function warranting preservation, and also identifies regions whose function is irrevocably gone.
The investigators propose a translational study applying Hyperpolarized Xenon (HXe) MRI to improve lung-health outcomes for lung cancer patients treated with radiation therapy. This study will focus on a patient cohort with significant heterogeneity: new patients with lung cancer and GOLD stage 3+ emphysema as a comorbidity and patients receiving RT for their second (primary) lung cancer. Optimizing radiation therapy treatment plans could provide a statistically significant benefit within a manageably small patient cohort. Maps will delineate three regions of functionality: regions of full function, having both ventilation and gas exchange to blood (where radiation should be avoided or minimized), regions where function is irrevocably absent (where radiation dose can be increased/maximized), and regions where function may be present or recoverable (where radiation should remain below or at the normal dose limit). Regions of lungs with absent function will have highest priority for receiving radiation during the RT procedure, while healthy regions will be avoided. It is expected that following this functional avoidance procedure will result in a decrease in the radiation induced lung injury reported events and a better outcome of the radiation treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1: open trial for establishing safety and methodology.
| Arm | Type | Receives |
|---|---|---|
| Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis. | Experimental | Combination Product: Hyperpolarized xenon MRIPatients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study. They will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. Patients will follow radiation therapy optimized for functional lung avoidance. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years with a diagnosis of non-small lung cancer and planned for a definitive course of radiation therapy.
- Preferred patients will have had successful radiation therapy for a prior lung cancer and developed a secondary lung cancer for which are to be treated.
- Other de-nuovo lung cancer patients planned for radiation therapy with lung heterogeneity from natural co-morbidities (e.g., COPD stage 3+).
Key exclusion criteria (12 listed)
- Patients less than 18 years old
- Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients,
- Any known contraindication to MRI examination
- Anyone with an implanted metal device
- Inability to provide informed consent
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 |
|---|---|---|
| Hyperpolarized xenon MRIPatients with non-small cell lung cancer scheduled for radiation therapy willing to take part in this study will undergo hyperpolarized xenon MRI at several time points prior and post RT. Images will be used to determine radiation treatment maps for functional lung avoidance. Reported adverse events caused by radiation induced lung injury and post-RT changes in the lung function will be compared to standard-of-care. | Combination product | Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis. |
Primary outcome
Changes in DLCO at 6-month post RT treatment.
Time frame: 1-year
Subjects will have measurements of DLCO at baseline (before RT) and at 6-month post RT. An independent-sample t-test will be used to compare change in DLCO.
4 secondary outcomes
Change in Quality of Life questionnaires from baseline to 6-month post-RT.
Time frame: 1-year
Change in HXe lung MRI metrics from baseline to 6-month post-RT.
Time frame: 1-year
Change in FEV1 from baseline to 6-month post-RT.
Time frame: 1-year
Incidence/severity of pneumonitis.
Time frame: 1-year
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 1 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperpolarized xenon MRI in people with Carcinoma, Non-Small-Cell Lung, run by Xemed LLC.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Karen Tang, B.S. (2672999618, karen.tang1@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in DLCO at 6-month post RT treatment. (time frame: 1-year). 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 1 Sep 2026.