Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions

Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions

Ventilation image-guided radiotherapy

Tokihiro Yamamoto, Ph.D.

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.

Novel Lung Functional Imaging for 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.

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.

The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.

The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.

University of California, Davis

Principal Investigator

Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions

Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions

Ventilation Image-guided Radiotherapy

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Analyst

Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy

Radiation Pneumonitis Graded by CTCAE v4.0

Patients who receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions and who receive stereotactic body radiotherapy (SBRT).

Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions

Ventilation Image-guided SBRT

Patients who receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions and who receive conventionally fractionated radiotherapy (CFRT).

Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions

Ventilation Image-guided CFRT

The number of participants analyzed are smaller than 33 due to missing data (disease progression or patient refusal was the main reason).

Spots Global Cancer Trial Database for image registration