Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PTV isodose coverage
研究概览
简要总结
A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than the spinal cord).
详细描述
This is a prospective, non-randomised radiotherapy planning study.
Subsets of patients with specific tumour and anatomical characteristics will benefit from improved PTV prescription isodose coverage, reduced spinal cord dose, and organs at risk dose by undergoing either prone or supine setup, planning and treatment. Both prone and supine CT radiotherapy planning scans for patients undergoing spine SBRT treatment will undergo comparison of radiotherapy plans to guide recommendation of prone treatment for future patients.
Patients continue to receive treatment in the proposed position as recommended y their treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •• Patients undergoing Cyberknife treatment to spinal metastasis
- •>18 years of age
- •Thoracic, lumbar and sacral spinal metastasis
- •Patients suitable to undergo radiotherapy planning CT scans in the prone position (treating physician assessed as having spinal stability).
- •All solid tumour types will be eligible
排除标准
- •• Primary spinal tumours
- •Vertebral disease resulting in unstable spinal vertebrae
- •Cervical tumours (patients will be unable to have a thermoplastic shell made for the prone position).
- •Patients with significant pain on prone lying (to be assessed by physician prior to consent)
- •Bilsky epidural score of 2 or greater (see appendix 1)
- •Pre-existing musculoskeletal chronic back medical diagnoses that would preclude CT scanning in the prone position.
研究组 & 干预措施
Supine
Patients undergo supine setup and imaging for radiation planning
干预措施: Setup and Imaging for at CT radiation planning (Other)
Prone
Patients undergo prone setup and imaging for radiation planning
干预措施: Setup and Imaging for at CT radiation planning (Other)
结局指标
主要结局
PTV isodose coverage
时间窗: Through study completion, an average of 1 year.
To compare the PTV coverage of radiotherapy plans delivered in prone and supine positions
次要结局
- Comfort scores(Immediate)
- Organs at risk dose(Immediate)
- CT and MRI registration(Immediate)
- Treatment time duration(Immediate)