Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The cumulative D2cc dose for rectum during brachytherapy
研究概览
简要总结
In this study, 5 subjects will be enrolled and the cumulative D2cc dose for rectum during brachytherapy will be recorded as the primary outcome measures.
详细描述
This is a phase I prospective study of 5 patients to determine if PEG hydrogel (ReSpace™) reduces the radiation dose delivered to the rectum during radiation therapy for cervical cancer by increasing the space between the cervix and the anterior rectal wall. In the other word, the purpose of this study is to assess whether the use of ReSpace™ hydrogel results in a reduction of radiation exposure to the anterior rectum.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.
- •Karnofsky score ≥
- •Subjects aged ≥ 18 years and ≤ 75 years.
- •Subjects must be able to cooperate in completing the entire study.
- •The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.
- •No contraindications to CT scanning.
- •Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form.
排除标准
- •Subjects who have received prior pelvic radiotherapy.
- •Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.)
- •Subjects with other primary malignancies
- •Subjects with contraindications to radiotherapy, as determined by the investigators
- •Subjects with injection site infections.
- •Subjects who are allergic to the ingredients of the device.
- •Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators
- •Persons with severe mental illness, cognitive impairment and thinking disorders.
- •Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening
- •Pregnant or lactating women or those who plan to get pregnant within the last six months
- •Subjects who cannot be followed up as prescribed by the doctor
- •Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollment
结局指标
主要结局
The cumulative D2cc dose for rectum during brachytherapy
时间窗: 21 days post index procedure
The mean of the cumulative rectum D2cc dose during brachytherapy will be calculated for subjects. which will be used to validate the parameter selection for phase II sample size estimation.
次要结局
- Evaluation of device performance of hydrogel spacer(during procedure)
- Injection volume of hydrogel spacer(during procedure)
- Implantation success rate of hydrogel spacer(during procedure)