Lung Functional Avoidance Radiotherapy Using Hyperpolarized Xenon MRI

Sponsor
Xemed LLC
Study ID
NCT07355231
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized xenon MRI — COMBINATION_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 Details

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.

Key Dates

First listed
Jan 21, 2026
Start date
Mar 1, 2027
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis.
    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.

Primary Outcome Measure

Changes in DLCO at 6-month post RT treatment. [ Time Frame: 1-year ]

Central Contacts

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