Safety and Efficacy of 3D Printing Coplanar Template Combined With CT Guided Radioactive I-125 Seed Implantation in the Treatment of Thoracic Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Local progression free survival
研究概览
简要总结
The main technical difficulties in radioactive iodine-125 seed implantation (RISI) lie in the complexity of operation and the control of operation quality. The current data shows that under the combined guidance of 3D-printing template and CT, the accuracy of RISI has been significantly improved, and the actual target dose could meet the design requirements of preoperative plan.
At present, 3D printing templates (3DPT) are divided into non-coplanar templates (3DPNCT) and coplanar templates (3DPCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of 3DPNCT, a considerable number of patients can also complete the treatment with 3DPCT. Moreover, compared with 3DPNCT, 3DPCT has the advantages of accurate needle path control, fast needle path adjustment, convenient for intraoperative real-time optimization, without waiting for printing time, easy for doctors to master, lower cost than 3DPNCT, and easy to carry out at the grass-roots level. Therefore, this study intends to explore 3DPCT technology to further clarify: (1) the accuracy of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors; (2) the short-term efficacy and toxicity of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors.
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
- •Pathological diagnosis of malignant tumor of chest, lesion diameter less than 7 cm.
- •There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by early treatment.
- •No bleeding tendency, anticoagulant therapy and / or antiplatelet coagulation drugs should be stopped for at least 1 week before treatment.
- •No serious or uncontrolled underlying diseases (such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction) are found.
- •There is a suitable puncture path, and the therapeutic dose is expected to be achieved.
- •KPS > 70, expected to tolerate puncture / seed implantation, and expected survival time greater than 3 months.
排除标准
- •Severe impairment of lung function (such as FEV1 < 40% predicted value, FVC < 50% predicted value, DLCO < 40% predicted value).
- •High risk of skin invasion and ulceration at the puncture site before treatment.
- •There is a large range of liquefaction and necrosis in the lesion, and the expected seed distribution would be poor.
- •Pregnant women, lactating women and mentally ill patients.
- •The patient with poor compliance and unable to complete the treatment.
- •Other conditions of the researchers who think it is not suitable to participate in this clinical trial.
结局指标
主要结局
Local progression free survival
时间窗: From the beginning of the treatment to 2 years after the treatment.
The time from the date of SBRT to the date of local recurrence or death or the date of last observation.
Incidence of adverse events
时间窗: From the beginning of the treatment to 2 years after the treatment.
The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured.
次要结局
- Overall survival(From the beginning of the treatment to 2 years after the treatment.)