BioXmark Liquid Fiducials to Enable Radiotherapy Tumor Boosting in Rectal Cancer, a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Positional stability of BioXmark liquid fiducial markers during the treatment course
研究概览
简要总结
To test the feasibility and accuracy of BioXmark fiducial markers for image guided radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course chemo-radiotherapy of the locally advanced rectal cancer.
详细描述
This study is a prospective non-randomized open label trial.
A total of 20 patients who will undergo neo-adjuvant chemo-radiotherapy for rectal cancer will be included in this study upon informed consent.
During an extra sigmoidoscopy after enema preparation, 4 liquid marker spots will be placed 1 cm from the tumor; two in the in the cranial and two in the caudal direction of the tumor (4 markers in total per patient).
Participants will undergo standard treatment for their rectal cancer.
As part of standard patient set-up directly before each radiotherapy treatment, kilovoltage (KV) cone-beam computed tomography (CBCT) will be acquired. Treatment positioning will be based on the regular clinical decision protocols for treatment of rectal cancer and not on the markers. During treatment potential fiducial movement will be assessed using an externally positioned ultra-sound probe (this probe will be positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum). Moreover, for patients in this study 2 orthogonal kV images will be made immediately after each radiation using the electronic portal imaging (EPI) device.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological or cytological proven adenocarcinoma of the rectum, treated with long course external beam radiotherapy
- •Age > 18 years
- •Have given written informed consent before patient registration
排除标准
- •Patients using anticoagulants: platelet aggregation inhibitors or coumarines
- •Iodine allergy
研究组 & 干预措施
BioXmark liquid fiducial markers
Placement of 4 BioXmark liquid fiducial markers, standard treatment (chemo-radiotherapy followed by surgery or wait-and-see) with extra imaging to evaluate the behaviour of the markers before, during and after the radiotherapy
干预措施: BioXmark liquid fiducial markers (Device)
BioXmark liquid fiducial markers
Placement of 4 BioXmark liquid fiducial markers, standard treatment (chemo-radiotherapy followed by surgery or wait-and-see) with extra imaging to evaluate the behaviour of the markers before, during and after the radiotherapy
干预措施: Imaging (Other)
BioXmark liquid fiducial markers
Placement of 4 BioXmark liquid fiducial markers, standard treatment (chemo-radiotherapy followed by surgery or wait-and-see) with extra imaging to evaluate the behaviour of the markers before, during and after the radiotherapy
干预措施: surgery or wait-and-see (Procedure)
结局指标
主要结局
Positional stability of BioXmark liquid fiducial markers during the treatment course
时间窗: will be determined through the course of radiotherapy, an average of 5 weeks
Positional stability / potential marker migration will be assessed by calculating marker pair distances.
次要结局
- Visibility/visual stability of BioXmark liquid fiducial markers during the treatment course(will be determined for the time interval between placement and the post-treatment MRI, an average of 12 weeks)
- Percentage of markers lost from injection to CT acquisition for RT planning(will be determined for the time intervals through the course of radiotherapy, an average of 5 weeks)
- Effect of BioXmark liquid fiducial markers on post-treatment MRI images(at the moment of the post-treatment MRI, on average 6-8 weeks after chemo-radiation)
- Adverse events (AE) potentially associated with BioXmark(until rectal surgery, on average 11 weeks, or in case of omission of surgery, until 3 months after marker placement.)
- Potential BioXmark induced alterations in the surgical specimen(on average 10-12 weeks after chemo-radiation)
- Inter-observer variation in gross tumor volume (GTV) localization with and without markers(through the course of radiotherapy, an average of 5 weeks)