In-vivo Treatment Verification for HDR Brachytherapy Patients Using an External Imaging Panel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dwell times
研究概览
简要总结
To acquire data during High Dose Rate (HDR) brachytherapy treatments aiming to track the brachytherapy source inside the patient verifying the delivery of the treatment plan.
Medical images (CT,MRI and US) combined with software developed by the investigator will be employed to predict the response of the Investigational product during the treatment and will be used as reference.The IP will be placed on the side of the treatment table and will acquire data during the whole treatment, which will be compared against information derived from the treatment plan. The IP based method can detect errors and information about motion and treatment uncertainties that are not currently available.
详细描述
Medical images (CT,MRI and US) combined with software developed by us will be employed to predict the response of the IP during the treatment and will be used as reference. The IP will be placed on the side of the treatment table and will acquire data during the whole treatment, which will be compared against information derived from the treatment plan. The IP based method can detect errors and information about motion and treatment uncertainties that are not currently available.
The IP will not change the workflow or be in contact with the patient since the panel will be placed on the side of a treatment table/bed at a safe distance from the patient. The data will be acquired automatically when radiation is detected and only two cables are necessary to power the system and collect the data. The cables will be placed in a convenient position together with the cables of the treatment table, not interfering with the clinical workflow. Clinical staff will not need to perform any extra actions during the whole process of the data acquisition.
The analysis of the data generated during the trial will be performed offline to avoid a possible interruption of the treatment due to any error (real or false) that may be detected using the system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment site Gynaecology (Endometrium/Cervix) and prostate
- •Treatment: HDR Brachytherapy
- •Patient will be treated on CT Couch
- •Mentally competent patient
排除标准
- •Incapacitated patient
结局指标
主要结局
Dwell times
时间窗: 1 year
Verify all relevant parameters of the HDR treatment plan during treatment delivery such as dwell times (time in seconds). Brachytherapy treatments are delivered using two parameters, the first parameter is dwell times (the duration the radioactive source stays in a dwell position, measured in seconds (s)). Our system measures dwell times, comparing them against expected values. Note that this parameter can be further used to derive other metrics, such as radiation dose distributions (units in Gray (Gy)), as defined by the TG-43 AAPM dose formalism.
Dwell position
时间窗: 1 year
Verify all relevant parameters of the HDR treatment plan during treatment delivery such as dwell positions (distance in (milli)meters). Brachytherapy treatments are delivered using two parameters, the second parameter is dwell positions (a location where the radioactive source should stop, defined in centimeters (cm)) Our system measures dwell positions, comparing them against expected values. Note that this parameter can be further used to derive other metrics, such as radiation dose distributions (units in Gray (Gy)), as defined by the TG-43 AAPM dose formalism.
次要结局
未报告次要终点