First-In Man (FIM) Study MR-Linac
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Geometrical accuracy of targeting by online MR imaging
研究概览
简要总结
Investigational device is the Magnetic resonance imager linear accelerator. Five (5) patients with bone metastases will be treated with palliative intention in this study. The goal is to confirm the pre-clinically demonstrated technical accuracy and safety of the newly developed MR-Linac in the clinical setting.
详细描述
This is a single center prospective proof of concept study including accuracy and safety aspects according to R-IDEAL stage 1 criteria. Five (5) patients with bone metastases will be treated with palliative intention in this study. Treatment will consist of a single fraction.
The MR linear accelerator (MRL) integrates a radiotherapy accelerator and a diagnostic quality 1.5T MRI, enabling soft-tissue visualization during the actual radiation delivery for improved targeting. This enables on-line treatment optimization for precise radiation delivery. Better visualization of the tumour targets and the surrounding healthy tissues, at the exact moment of treatment, makes it possible to adapt the dose to the actual anatomy while optimally sparing normal tissues.
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
- •In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- •Painful bone metastases in the lumbar spine
- •Radiographic evidence of bone metastases
- •Histologic proof of malignancy (primary carcinoma)
- •Karnofsky Performance Score ≥ 50
- •Age ≥ 18 years
- •Able to provide written informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Prior radiation therapy within the region planned to be irradiated
- •Contraindication for MRI according to screening protocol radiology department UMCU (e.g. cardiac pacemakers, and defibrillators, artificial heart valves or cochlear implants, https://richtlijn.mijnumc.nl/Beeld/MRI/Paginas/MRI-Veiligheid-Contra-indicaties.aspx
- •Claustrophobia
- •Standard systemic anti-cancer therapy or radionuclide therapy within 48 hours before or after treatment.
- •Any other type of not standard systemic anti-cancer treatment, except for endocrine treatment.
- •Unstable spine requiring surgical stabilization
- •Neurological deficit due to bone metastasis
研究组 & 干预措施
treatment arm
Single arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac).
干预措施: Magnetic resonance imager linear accelerator (Device)
结局指标
主要结局
Geometrical accuracy of targeting by online MR imaging
时间窗: During treatment (day 0)
Geometrical accuracy: will be checked online by using the MRI in combination with VolumeTool visualization and off-line by comparison of the EPID beam data with the prescribed beam data. A positioning error of ≤ 5 mm will be considered acceptable
Safety of the treatment system (a dose distribution accuracy ≤ 5% will be considered acceptable). Incidence of acute toxicity (CTCAE grade 2 are higher) and incidence of Serious (unexpected) Adverse Events will be measured.
时间窗: During treatment (Day 0). For patient safety patients will be contacted at day 1, week 2 and week 12 after treatment.
Safety of the system: System behaves in accordance with the workflow and risk mitigation plan, Dosimetric safety: An independent dosimetry check before start irradiation (Oncentra) and an independent dosimetry during irradiation (second chamber) will be used. For the overall process a dose distribution accuracy ≤ 5% will be considered acceptable. Patients safety: by reporting any acute toxicity \> grade 2 (according CTCAE version 4.0 for acute toxicity) and any Serious (Unexpected) Adverse Events (S(U)AE) within 12 weeks after treatment
次要结局
- Descriptive analysis of the clinical workflow by keeping a log book for the entire procedure.(During treatment (day 0))
- Patients comfort(immediately after treatment (day 0))