Intra-operative Use of C-arm Cone-beam CT for Quality Assurance of Low-dose-rate Prostate Brachytherapy Dose Delivery
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Dosimetric accuracy
研究概览
简要总结
The investigators will assess the feasibility of intraoperative use of C-arm cone-beam CT imaging for intraoperative dosimetric evaluation in prostate low-dose-rate (LDR) brachytherapy. Patients recruited are those who will receive standard LDR brachytherapy for prostate cancer treatment. Consenting patients will undergo additional 3D C-arm cone-beam CT imaging (3D C-arm) and motorized trans-rectal ultrasound (TRUS). Volumetric and dosimetric measures will be compared to those using the standard Day-0 CT images. The investigators hope that the intraoperative 3D C-arm provides quality assurance measures sufficient to eliminate the need for Day-0 CT LDR brachytherapy and provide the opportunity for intraoperative modification of seed delivery plan.
详细描述
- Objectives
- The primary objective of this study is to determine the feasibility of replacing Day-0 CT with intra-operative 3D C-arm imaging. The main benefit of this change is to receive immediate feedback on the quality of treatment. This can lead to the possibility of performing "live" adjustments to the treatment plan based on feedback of actual seed positions achieved after implantation.
- Secondly, by replacing Day-0 CT, a separate scan performed in a different site will be eliminated from the treatment procedure, freeing up the CT scanner for other clinical uses
- Hypotheses
- Primary hypothesis: Intraoperative use of 3D C-arm cone-beam CT can eliminate the need for Day-0 CT for post-implant dosimetry in prostate LDR brachytherapy by providing similar or improved dosimetric accuracy
- Secondary hypothesis 1: Dosimetric values obtained with the TRUS probe inside the rectum are not significantly different from those measured when the probe is outside the rectum
- Secondary hypothesis 2: Sagittal TRUS imaging provides better seed and boudnary detection for dosimetric purposes compared to transverse imaging
- Justification
Standard post-implant quality assessment at the BC Cancer Agency involves a pelvic CT 2-3 hours after treatment. This scan is performed outside the operating room, in a different location. As a result, it is not possible to receive immediate feedback on the quality of treatment. Furthermore, soft tissue visualization is poor in CT imaging and contouring variability is large. The use of other imaging modalities such as ultrasound would be beneficial. However, since the scan is performed at a different time, and with the patient in a different position, registering the images would be challenging.
Intra-operative C-arm CT imaging would provide immediate feedback on the quality of treatment, provide the opportunity of using information from intra-operative ultrasound imaging for soft tissue visualization, and eliminate the need for a separate scan in a different location. 4. Research method
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years of age or older
- •Must be able to give informed consent
- •Must have been diagnosed with prostate cancer, as determined by a prostate biopsy
- •Must not have had any prior history of cancer. Participants that have had some types of skins cancer are still able to participate
- •Must be eligible for and receiving low-dose-rate prostate brachytherapy
排除标准
- •They are unable to undergo general or spinal anesthesia
- •They are on anticoagulation therapy (blood thinners)
- •They have had previous radiotherapy to the pelvis
研究组 & 干预措施
Imaging interventions
Eligible patients who consent to participate in this study will undergo a combination of 4 different imaging interventions (based on the group they're in, as described in the protocol), intra-operatively, in addition to their standard LDR brachytherapy treatment.
干预措施: Intra-operative C-arm CT imaging (Procedure)
结局指标
主要结局
Dosimetric accuracy
时间窗: 12 months
To determine if the intraoperative use of 3D C-arm cone-beam CT can eliminate the need for D-0 Ct for post-implant dosimetry in prostate LDR brachytherapy by providing similar or improved dosimetric accuracy
次要结局
- Seed and boundary detection(12 months)
- Dosimetric values(12 months)