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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05302817.
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.
Lead OrganizationXemed LLC
