A Single-centre Feasibility Study Investigating the Use of in Vivo Dosimetry in Patients Receiving High Dose Rate (HDR) Brachytherapy for Gynaecological and Prostate Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess the feasibility of in vivo dosimetry in HDR brachytherapy and compare the calculated dose against measured dose
研究概览
简要总结
The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).
详细描述
A dosimeter is a small device that is able to record the dose of radiation received. It can provide an independent check that the dose of radiation delivered matches the dose calculated for patients receiving radiotherapy as part of their cancer treatment.
The purpose of this study is to investigate the clinical use of in vivo dosimeters for brachytherapy. Two types of dosimeters will be used; micro metal oxide field effect transistors (microMOSFETs) and Thermoluminescent detectors (TLDs). These will be placed into the rectum (back passage), urethra (the tube through which urine leave the body from the bladder) and within or near (typically within a few centimetres) to the cancer itself. These devices will record the dose of radiation received at the time of brachytherapy at each of these sites and we will compare that measurement with the expected measurement based on the calculations we made in planning the patient's treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and above
- •Patients receiving HDR brachytherapy using iridium-192 (192Ir) radioactive source either as a monotherapy or in combination with external beam radiotherapy for:
- •histologically/radiologically proven primary or locally recurrent prostate cancer
- •locally advanced gynaecological malignancy in the primary and recurrent setting
- •primary cervix carcinoma (squamous, adenocarcinoma, adenosquamous) FIGO IB2-IVA
- •primary vulval FIGO I-IVA
- •primary vaginal FIGO I-IVA
- •primary endometrial cancer FIGO Stage I-IVA (not suitable for surgery)
- •endometrial cancer receiving adjuvant vaginal vault brachytherapy
- •recurrent cervix, vulval, vaginal or endometrial cancer suitable for brachytherapy as discussed in a regional gynae-oncology multidisciplinary meeting.
- •World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) performance status 0-2
排除标准
- •Previous brachytherapy exposure to the treatment site
- •Patients unable to give informed consent
- •Patients unable to have a regional or general anaesthetic
- •Patients with the following medical conditions: coagulopathies, history of another primary malignancy, known allergy or sensitivity to study materials; previous or current fistulae
- •Not able to understand the implications of participating in the study in English
- •Patients with recent (within the last 6 months) or currently participating in interventional research
结局指标
主要结局
To assess the feasibility of in vivo dosimetry in HDR brachytherapy and compare the calculated dose against measured dose
时间窗: 12 months
Measured by comparing the calculated (treatment planning system (TPS)) dose against the measured dose (using micro silica thermo-luminescent dosimeters (TLDs) and micro metal oxide field effect transistors (MOSFETS)). The measured dose will be compared to the calculated dose by the TPS at the bladder neck, anterior rectal wall, recto-vaginal point (gynaecological cases) and within the clinical target volume (CTV) for each fraction as well for the whole treatment.
次要结局
- Review of investigative and corrective action(12 months)