Xenon MRI–guided radiation for lung cancer

Image-Based Functionally Adapted Radiation Therapy for Lung Cancer

This project will try using hyperpolarized xenon MRI to map which parts of the lungs are working and guide stereotactic body radiation therapy to spare healthy lung in people with lung cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Iowa (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT06925295 on ClinicalTrials.gov

What this trial studies

This pilot interventional Phase 2 project uses hyperpolarized xenon (Xe) MRI to create regional maps of lung ventilation and gas exchange before and during a course of stereotactic body radiation therapy (SBRT). The team will develop automated software tools to integrate these functional MRI maps with standard anatomic imaging and radiation treatment planning systems to steer dose away from well-functioning lung regions. Participants will undergo Xe MRI scans, pulmonary function tests, and quality-of-life and dyspnea questionnaires to track short- and longer-term changes. The goal is to compare outcomes of function-informed RT planning with conventional planning approaches to see if functional guidance reduces healthy-lung dose and preserves lung function and quality of life.

Who should consider this trial

Good fit: Adults aged 18–80 with a clinical diagnosis of lung cancer who are planned for stereotactic body radiation therapy and can safely undergo MRI and provide informed consent are the ideal candidates.

Not a fit: Patients who cannot have MRI (MRI contraindications), are pregnant or lactating, have resting oxygen saturation <90% on supplemental oxygen, recent respiratory infection, or otherwise cannot complete in-person imaging and treatment visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce radiation damage to healthy lung, lower rates of acute and chronic lung toxicity, and help preserve long-term lung function and quality of life.

How similar studies have performed: Early research using functional lung imaging including hyperpolarized gas MRI has produced promising images of ventilation and gas exchange, but using Xe MRI to guide RT planning remains novel and not yet proven to improve clinical outcomes.

Eligibility criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial

1. Aged 18-80 years
2. Willing and able to provide informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
3. 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

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial:

1. Subject is less than 18 years old or incarcerated
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Resting oxygen saturation \<90% on supplemental oxygen
5. Respiratory illness of bacterial or viral etiology within 30 days of planned treatment
6. Subject has history of any known ventricular cardiac arrhythmia
7. Subject has history of cardiac arrest within the last year
8. Subject has prior history of cancer treatment with radiation therapy to the lung
9. Subject has concurrent cancer treatment with agents associated with increased risk of radiation pneumonitis (e.g. immunotherapy, chemotherapy)
10. Subject does not fit into 129Xe vest coil used for MRI
11. Subject cannot hold his/her breath for 15 seconds
12. Subject deemed unlikely to be able to comply with instructions during imaging
13. 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

Where this trial is running

Iowa City, Iowa

• University of Iowa — Iowa City, Iowa, United States (RECRUITING)

Study contacts

• Principal investigator: Sean Fain, PhD — University of Iowa
• Study coordinator: Eric Bruening

Conditions: Imaging Techniques, Lung cancer, Xenon, Imaging