Carcinoma, Non-Small-Cell LungPhase 1NCT05302817
Functional Lung Avoidance Radiation Therapy Using Hyperpolarized Xenon-129 MRI
A Phase 1 study testing Hyperpolarized xenon MRI in people with Carcinoma, Non-Small-Cell Lung, run by Xemed LLC at 1 site in United States.
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 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
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2023to 28 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
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 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 biomarker. 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 reduced), regions where function is irrevocably absent (where radiation dose can be increased), and regions where function may be present or recoverable (where radiation should remain at the normal dose limit). In the first year the investigators will conduct an open-label Phase 1 clinical trial to optimize the hardware and functional imaging protocols, as well as generate and perform targeted RT treatment in a limited number of patients, with safety as the primary endpoint.
- 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 maps for functional lung avoidance and post-RT changes in the lung function and compared to standard-of-care assessment methods.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis. | Experimental | Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study, where 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. However, for this part of the study, subjects will still follow the standard-of-care radiation treatment plan. 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 |
| 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.
Number of patients reporting one or more adverse events related to hyperpolarized xenon inhalation in this population.
Phase 1 will assess safety of inhaling hyperpolarized xenon in this patient population with severely affected lung function.
Measured: One year.
Secondary outcomes (1)
Number of patients with radiation therapy related adverse events as assessed by CTCAE v4.0.
First 10 patients enrolled in this study will have standard-of-care radiation therapy, and 10 more will have RT planned with functional lung avoidance maps based on HXe MRI. All patients will be monitored and followed for study related adverse events as assessed by CTCAE v4.0.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start17 Mar 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Why it stopped: Regulatory compliance.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1: open trial for establishing safety and methodology. Phase 1, Part 1: 10 subjects enrolled for establishing methodology for guiding radiation therapy using HXe MRI. Radiation treatment will follow standard-of-care.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
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
- NCT05302817
- Sponsor's protocol ID
- 849026
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2022
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Lung Avoidance Radiation Therapy Using Hyperpolarized Xenon-129 MRI
- ClinicalTrials.gov ID
- NCT05302817
- Acronym / sponsor ID
- 849026
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Regulatory compliance.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Xemed LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 31 Mar 2022 (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 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 biomarker. 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 reduced), regions where function is irrevocably absent (where radiation dose can be increased), and regions where function may be present or recoverable (where radiation should remain at the normal dose limit). In the first year the investigators will conduct an open-label Phase 1 clinical trial to optimize the hardware and functional imaging protocols, as well as generate and perform targeted RT treatment in a limited number of patients, with safety as the primary endpoint.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: open trial for establishing safety and methodology. Phase 1, Part 1: 10 subjects enrolled for establishing methodology for guiding radiation therapy using HXe MRI. Radiation treatment will follow standard-of-care.
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis. | Experimental | Combination Product: Hyperpolarized xenon MRIPatients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study, where 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. However, for this part of the study, subjects will still follow the standard-of-care radiation treatment plan. 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. |
| 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 maps for functional lung avoidance and post-RT changes in the lung function and compared to standard-of-care assessment methods. | Combination product | Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis., Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis. |
Primary outcome
Number of patients reporting one or more adverse events related to hyperpolarized xenon inhalation in this population.
Time frame: One year.
Phase 1 will assess safety of inhaling hyperpolarized xenon in this patient population with severely affected lung function.
1 secondary outcome
Number of patients with radiation therapy related adverse events as assessed by CTCAE v4.0.
Time frame: One year.
Results and safety
The study was stopped early (reason given: Regulatory compliance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperpolarized xenon MRI in people with Carcinoma, Non-Small-Cell Lung, run by Xemed LLC 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 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: stopped early, as of the sponsor's last update on 20 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Regulatory compliance.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reporting one or more adverse events related to hyperpolarized xenon inhalation in this population. (time frame: One 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 20 Jan 2026.