Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Dosimetry (D90) between pre-plan and post-plan
研究概览
简要总结
In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice.
In previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for head and neck cancer. However, the accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Ages 18 to 85
- •Single or multiple abdominal or pelvic tumors (solid, partially solid)
- •Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
- •KPS>60 points with expected survival >3 months, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
- •Planned seed implantation with applicable puncture path
- •With informed consent.
排除标准
- •Poor organ function (e.g. Liver decompensation)
- •The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
- •Poor compliance, unable to complete coordination
- •Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
结局指标
主要结局
Dosimetry (D90) between pre-plan and post-plan
时间窗: From the starting to the ending of the seed implantation (generally within 1 week).
Dose covering 90% of target volume between pre-plan and post-plan
次要结局
- Success rate of seed implantation(From the starting to the ending of the seed implantation (generally within 1 day).)
- Local progression-free survival(From date of seed implantation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- Operating duration(From the starting to the ending of the seed implantation (generally within 2 hours))
- Adverse event(Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.)
研究者
Qiu Bin
Principal Investigator
Peking University Third Hospital