Clinical Study on 4DCT-Based Pulmonary Ventilation Imaging for Functional Lung Avoidance in Radiotherapy of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Incidence of Radiation-Induced Lung Injury (Grade ≥2)
研究概览
简要总结
This retrospective single-center study investigates whether four-dimensional CT (4DCT)-based lung ventilation imaging can guide functional lung avoidance radiotherapy (FLAR) for patients with primary lung cancer.
Ventilation maps generated from planning 4DCT are used to identify well-ventilated lung regions, enabling paired comparison between functional lung avoidance radiotherapy plans and conventional anatomic radiotherapy plans.
The study aims to assess whether incorporating functional lung information into radiotherapy planning can reduce radiation exposure to well-ventilated lung while maintaining adequate tumor coverage, and to explore its relationship with radiation-induced lung injury.
All analyses are based on existing clinical imaging, treatment planning data, and follow-up records. No additional interventions, imaging, or procedures are performed as part of this study.
详细描述
This study retrospectively evaluates a functional lung-guided radiotherapy planning workflow based on four-dimensional CT (4DCT) ventilation imaging in patients with primary lung cancer who previously underwent thoracic radiotherapy.
High-quality 4DCT datasets acquired during routine simulation are processed to generate voxel-based lung ventilation maps using deformable image registration and Jacobian-based computational methods. These ventilation maps are spatially registered to planning CT images and incorporated into the treatment planning system to delineate high-function lung subregions.
For each eligible patient, paired radiotherapy plans are retrospectively generated and analyzed: a conventional anatomic radiotherapy plan and a functional lung avoidance radiotherapy (FLAR) plan that incorporates ventilation-defined avoidance structures. Both plans are optimized to achieve comparable target coverage while differing in lung avoidance strategy.
Dosimetric and clinical data are obtained from existing treatment planning records and routine clinical follow-up to support comparative analyses of functional lung sparing and associated pulmonary outcomes. All analyses are conducted retrospectively using data derived from standard clinical care. No prospective enrollment, additional imaging, or study-specific interventions are performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary lung cancer (adenocarcinoma, squamous cell carcinoma, or small-cell carcinoma) treated with thoracic radiotherapy.
- •High-quality 4DCT scans performed before radiotherapy, enabling generation of ventilation or perfusion maps.
- •Radiotherapy plans designed using IMRT.
- •Availability of both functional lung avoidance plans and conventional anatomical radiotherapy plans for paired analysis.
- •Complete treatment and follow-up records, including radiation-induced lung injury (e.g., radiation pneumonitis) and pulmonary function tests.
排除标准
- •Incomplete or poor-quality imaging data preventing accurate ventilation/perfusion map generation.
- •Radiotherapy interrupted or incomplete for any reason.
- •Severe underlying lung diseases (e.g., extensive emphysema, pulmonary fibrosis, active tuberculosis) that may confound treatment outcomes or toxicity assessment.
- •Presence of other untreated primary malignancies during the study period.
- •Prior lung surgery or local therapies (e.g., ablation) that may affect evaluation of radiation-induced lung injury.
- •Missing follow-up data, making assessment of radiation-induced lung injury or long-term lung function changes impossible.
研究组 & 干预措施
4DCT-IMRT Lung Cancer Cohort
Single-center retrospective cohort of consecutive lung cancer patients with high-quality 4DCT planned with IMRT (2022-01-01-2025-09-09; actual enrollment = 202). 4DCT-based ventilation maps delineate high-function lung. Paired-plan comparison of functional-lung-avoidance versus conventional plans; primary outcomes: dose to high-function lung and radiation pneumonitis. Secondary outcomes: doses to heart, spinal cord, and esophagus, and plan-quality metrics (e.g., MLD, V20, DVH). No additional procedures or treatments.
结局指标
主要结局
Incidence of Radiation-Induced Lung Injury (Grade ≥2)
时间窗: Assessed at 3 months, 6 months, and 12 months after completion of radiotherapy.
Incidence of radiation-induced lung injury (RILI) of Grade ≥ 2, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to adverse event), with higher grades indicating more severe toxicity. The primary outcome is the proportion of patients experiencing CTCAE Grade ≥ 2 RILI.
次要结局
- Mean Dose to High-Function Lung (Gy)(At baseline treatment planning (prior to radiotherapy delivery).)
- MLD for Whole Lung (Gy)(At treatment planning (baseline, pre-radiotherapy delivery).)
- V5 of High-Function Lung (%)(At baseline treatment planning (prior to radiotherapy delivery).)
- V20 of High-Function Lung(At baseline treatment planning (prior to radiotherapy delivery).)
- Mean Dose to Heart (Gy)(At treatment planning (baseline, pre-radiotherapy delivery).)
- Maximum Dose to Esophagus (Gy)(At treatment planning (baseline, pre-radiotherapy delivery).)
- Maximum Dose to Spinal Cord (Gy)(At treatment planning (baseline, pre-radiotherapy delivery).)
- Target Coverage (PTV D95)(At treatment planning (baseline, pre-radiotherapy delivery).)
- Conformity Index of Radiotherapy Plans(At treatment planning (baseline, pre-radiotherapy delivery).)
- Homogeneity Index of Radiotherapy Plans(At treatment planning (baseline, pre-radiotherapy delivery).)
研究者
ZhenZhou Yang
Professor of Radiation Oncology, Cancer Center, Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University