Functional Outcomes for Stereotactic Body Radiotherapy of Lung Lesions in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Longitudinal Changes in Lung Function
研究概览
简要总结
Little is known about the safety of body radiation therapy (SBRT), especially the impact on pulmonary function, quality of life, and on functional changes within the lung itself. Radiation dose constraints and capturing functional changes on imaging are not well studied in this setting.
The current study aims to evaluate the utility of advanced imaging to measure lung function prior to and after treatment and to assess the feasibility of using this data to adapt SBRT planning.
详细描述
Stereotactic body radiation therapy (SBRT) is becoming a new standard for unresectable lung metastases and primary lung cancers.
However, it is becoming increasingly common for patients to undergo multiple courses of lung SBRT to synchronous and/or metachronous lung lesions. Further, the indications for SBRT are being expanded to patients who have very poor pulmonary function such as FEV1 < 0.5 L or DLCO < 35% predicted, who have large tumors (>3 cm), or who have centrally located lesions that abut great vessels and mainstem bronchi. Little is known about the safety of such treatments, especially the impact on pulmonary function, quality of life, and on functional changes within the lung itself. Radiation dose constraints and capturing functional changes on imaging are not well studied in this setting.
The current study aims to evaluate the utility of advanced imaging to measure lung function prior to and after treatment and to assess the feasibility of using this data to adapt SBRT planning. SPECT/CT will be used to measure ventilation and perfusion changes while. CT ventilation scans will be used to correlate functional changes observed on diagnostic SPECT/CT. Dynamic contrast enhanced MRI (DCE-MRI) will also be used to explore local vascular changes in the treated tumor. In patients whose tumors lie close to the heart, cardiac MRI will be used to investigate whether high doses of radiation per fraction are associated with changes in cardiac function. These imaging modalities may be used to potentially predict toxicity and patient response with the ultimate goal of prospectively adapt dose to individual patient and tumor characteristics. Lung function prior to and post-treatment will also be measured as a correlate of functional imaging changes. Identifying areas of the lung that are sub-functional or low-functioning may offer an opportunity to adapt stereotactic ablations that spare functional lung thereby making SBRT treatments to higher risk patients safer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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 receiving SBRT lung treatment and who have any one of the following high risk features:
- •Lung lesion > 5 cm
- •DLCO < 35%
- •FEV1 < 0.5 L
- •Central lung tumors (defined as within 2 cm from the proximal bronchial tree)
- •Tumors that abut the great vessels, trachea, spinal cord, or esophagus
- •Prior lobectomy or pneumonectomy
- •Prior lung radiation (SBRT or conventional definitive lung radiation)
- •Patients must be 18 years of age or older
排除标准
- •Patients who have received targeted agents or systemic potentially radiosensitizing chemotherapy within 2 weeks of lung SBRT start
- •Pregnancy or lactation
- •Unable to tolerate MRI without anesthesia
- •Inability cooperate with the scans
结局指标
主要结局
Longitudinal Changes in Lung Function
时间窗: From baseline to 6 months post Radiation Treatment
To characterize longitudinal changes in lung function using SPECT/CT and CT ventilation scans in "high risk" patients undergoing standard SBRT treatments.
次要结局
- To Assess Early Vascular Changes Using DCE-MRI(From baseline to 6 months post Radiation Treatment)
- Dosimetric Predictors to Assess Changes in Toxicity(From baseline to 6 months post Radiation Treatment)
- Changes in SPECT-CT Correlate with Changes in CT Ventilation(From baseline to 6 months post Radiation Treatment)