Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- To determine whether a functional planning guided by lung perfusion PET/CT imaging is superior to a conventional anatomical planning with regards to the occurrence of grade 2 or higher lung toxicity during the year following lung SBRT.
研究概览
简要总结
Stereotactic body radiotherapy (SBRT) has an increasing role in the treatment of both primary and secondary lung tumors. However, lung SBRT remains associated with significant radiation induced lung injury (RILI). Indeed, the reported incidence of symptomatic radiation induced lung injury (grade≥2) in the published literature is up to 20%. A current challenge of lung SBRT is therefore to better preserve lung function and to reduce pulmonary toxicity.
During standard lung SBRT planning, dose constraints are defined on the anatomical lung volume. This planning considers the lung as functionally uniform and does not take into account the variability of regional lung function distribution. Functional lung avoidance is an emerging concept in lung radiotherapy (RT). The technique aims at personalizing RT treatment planning to individuals' lung functional distribution, by sparing functional pulmonary areas while prioritizing delivery of high doses to non-functional regions.
68Ga-MAA lung perfusion PET/CT is a novel imaging modality for regional lung function assessment. As compared with conventional lung scintigraphy, lung perfusion PET/CT is inherently a vastly superior technology for image acquisition (higher sensitivity and spatial resolution, greater access to respiratory gated acquisition). A more accurate lung functional mapping improves the possibility of functional lung avoidance planning for SBRT.
The hypothesis is that functional lung avoidance planning guided by 68Ga-MAA perfusion PET/CT, while delivering an optimal dose to the tumor, will reduce the frequency of RILI in patients treated with lung SBRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged > 18 years planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors will be eligible to participate into the study
排除标准
- •Inability to give informed consent
- •Patientsunder guardianship or curatorship
- •Pregnant or breastfeeding women.
- •Contraindications to the radiolabeled product infused for lung perfusion PET/CT.
研究组 & 干预措施
Control group:
A conventional anatomical planning will be performed.
干预措施: Conventional anatomical planning radiotherapy (Radiation)
Experimental group
functional planning will be carried out, respecting the standard constraints especially to the tumor and the anatomical lung volume, but also incorporating "lung functional volume" constraints defined by regional lung function mapping.
干预措施: Functional Lung avoidance planning (Radiation)
结局指标
主要结局
To determine whether a functional planning guided by lung perfusion PET/CT imaging is superior to a conventional anatomical planning with regards to the occurrence of grade 2 or higher lung toxicity during the year following lung SBRT.
时间窗: At year after baseline
Occurrence of symptomatic RILI (grade≥2 lung toxicity as assessed using the CTCAE 5.0) during the year following lung SBRT. This evaluation will be performed by a medical oncologist blinded from the allocated arm.
次要结局
- quality of life assessment(Measured at 3, 6, 9 and 12 months after baseline)
- Progression-free survival;(Measured at 3, 6, 9, and 12 months after baseline)
- Overall survival.(at 12 months after baseline)
- Grade 3 or higher RILI(Measured at 3, 6, 9, and 12 months after baseline)
- Local tumor control;(Measured at 3, 6, 9, and 12 months after baseline)
- quality of life assessment(Measured at 3, 6, 9, and 12 months after baseline)