Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 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 prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy.
All participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison.
The primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age 18 to 85 years (inclusive); any sex.
- •Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).
- •Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT/VMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.
- •Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-
- •No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.
- •Able to comply with treatment and follow-up assessments.
- •Written informed consent provided.
排除标准
- •Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.
- •Age <18 or >85 years.
- •Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).
- •Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.
- •Concurrent other active/advanced malignancy requiring priority treatment that would confound study outcomes.
- •Recent participation in another interventional clinical trial or concurrent investigational therapy judged likely to interfere with this study's endpoints.
- •Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and/or scheduled follow-up.
- •Inadequate 4DCT image quality or inability to generate/validate the 4DCT ventilation map required for functional-lung-guided planning.
- •Any other condition deemed unsuitable by the investigators in the interest of participant safety.
研究组 & 干预措施
4DCT-FLI-Guided Functional Lung Avoidance Radiotherapy (FLAR)
Participants receive IMRT planned with 4DCT ventilation functional imaging guidance. A ventilation map is generated from 4DCT, high-function lung (top 80% ventilation) is contoured, and the treatment plan is optimized to spare high-function lung while maintaining target coverage and meeting standard OAR constraints. A conventional anatomic plan is also generated for within-patient dosimetric comparison.
干预措施: 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR) (Procedure)
结局指标
主要结局
Incidence of Radiation-Induced Lung Injury (Grade ≥2)
时间窗: Time Frame: 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 baseline treatment planning (prior to 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).)
- Gradient Measure (GM) of Radiotherapy Plans(At treatment planning (baseline, pre-radiotherapy delivery).)
- Forced Expiratory Volume in 1 Second (FEV1)(Baseline and 1, 3, 6, and 12 months after radiotherapy.)
- Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(Baseline and 1, 3, 6, and 12 months after radiotherapy.)
- Forced Vital Capacity (FVC)(Baseline and 1, 3, 6, and 12 months after radiotherapy.)
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