Novel Lung Functional Imaging for Personalized Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
时间窗: 12 months
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.
次要结局
- Radiation Pneumonitis Graded by CTCAE v4.0(2 years)
- Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)(Baseline and 6 months)
- Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(Baseline and 6 months)
研究者
Tokihiro Yamamoto, Ph.D
Principal Investigator
University of California, Davis