The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.
In this clinical trial, the investigators will assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy. The investigators will deliver personalized radiotherapy treatments that selectively avoid irradiating highly-functional lung regions for lung cancer patients, and follow up patients to assess the safety and feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided personalized radiotherapy can be delivered safely for lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
University of California Davis Medical Center
Sacramento, California, United States
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.
Time frame: 12 months
Radiation Pneumonitis Graded by CTCAE v4.0
Number of participants with Grade ≥ 2 radiation pneumonitis adverse event graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time frame: 2 years
Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)
The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.
Time frame: Baseline and 6 months
Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.
Time frame: Baseline and 6 months
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