Phase I Feasibility Study of Accounting for Relative Motion of Multiple Targets in Prostate Cancer Radiotherapy Using Realtime Multi-leaf Collimator Adaptation and Kilovoltage (kV) Intrafraction Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Software or mechanical failure
研究概览
简要总结
Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimise side effects to the critical organs.
详细描述
This study will assess the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimising side effects to the critical organs.
During radiation treatment, the prostate position will be monitored in real time using the KIM technology. The nodal target will be imaged before and after each treatment to evaluate the nodal treatment margin. The MLC tracking is implemented by recalculating the radiation beam shape fit for the moved prostate and static nodal targets and sending the adjusted MLC leaf positions to the treatment delivery system. The actually delivered dose to the patient will be calculated after the treatment and compared to the dose without MLC tracking to assess the treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing definitive external beam radiotherapy at Northern Sydney Cancer Centre
- •Patients histologically proven prostate adenocarcinoma
- •PSA obtained within 3 months prior to enrolment
- •Pelvic lymph nodes are included for treatment for patients at stage T1c-T3b with Gleason 8-10 or prostate-specific antigen (PSA) > 20 ng/ml or pelvic lymph node positivity on conventional imaging or prostate-specific membrane antigen (PSMA) scans.
- •Patient must be able to have gold fiducial markers placed in the prostate
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Ability to understand and the willingness to sign a written informed consent document.
- •Prostate dimension that allows leaf span with tracking margin of ±8mm
排除标准
- •Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
- •Patient's dimensions >40cm as measured at the level of the prostate
- •Patients with overlapping implanted gold fiducials in x-ray imaging
研究组 & 干预措施
Stage 1: Optimise nodal treatment margin
During Stage 1: Optimise nodal treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. The nodal target position stability will be evaluated by the cone beam computed tomography (CBCT) imaging before and after each treatment session for the first 10 patients.
干预措施: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' (Device)
Stage 2: Use treatment margin
During Stage 2: Use treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. At the same time, multi-leaf collimator (MLC) tracking will be used to reshape the radiation beam in real-time using the margin size determined in Stage 1.
干预措施: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' (Device)
结局指标
主要结局
Software or mechanical failure
时间窗: The treatment period (2-9 weeks)
The percentage of fractions delivered without software or mechanical failure
次要结局
- Geometric accuracy(The treatment period (2-9 weeks))
- Prostate motion trajectory(Treatment period (2-9 weeks))
- Acute toxicity(Treatment period (2-9 weeks) plus 3 months)
- Dosimetric accuracy(Treatment period (2-9 weeks))
研究者
Professor Thomas Eade
Head of Research
Royal North Shore Hospital