Novel Lung Functional Imaging for Personalized Radiotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Novel Lung Functional Imaging for Personalized Radiotherapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: Ventilation image-guided radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR). Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age. There are no gender or ethnic restrictions. Concurrent chemotherapy is allowed, but not required. Life expectancy with treatment should be ≥6 months in the estimation of the treating physicians. Zubrod performance status ≤2 Adequate marrow and hepatic function defined as Hgb ≥8; platelets ≥100k; ANC≥1500; LFTs ≤2x upper limit of normal and creatinine ≤1.3 or creatinine clearance of ≥50 Patient must be able to provide study specific informed consent prior to study entry. Exclusion Criteria: Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of planned radiotherapy fields. For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible. For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system. Children (<18 years of age), pregnant women, University of California employees or students, or prisoners will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilation image-guided radiotherapy<br>Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions | Radiation: Ventilation image-guided radiotherapy<br>* Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Pulmonary Functional Imaging, Computed Tomography (CT), Image Registration, Functional Image-guided Radiotherapy