Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Incidence of brain radionecrosis
研究概览
简要总结
High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years;
- •Ability to express appropriate informed consent to treatment;
- •Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;
- •In case of recurrence, confirmation can be either histological or radiological;
- •Not previous brain-level radiotherapy;
- •Performance status: ECOG=0-2.
排除标准
- •Refusal to radiation treatment (i.e., absence of signed informed consent);
- •Other concomitant oncologic therapies
- •Current pregnancy;
- •Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;
- •Inability to perform MRI with MoC or PET.
研究组 & 干预措施
Dose escalation of radiation therapy, based on somatostatin receptor PET imaging
Radiation treatment with higher doses than the standard and defined using PET imaging
干预措施: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging (Radiation)
结局指标
主要结局
Incidence of brain radionecrosis
时间窗: up to 13 years
Incidence of symptomatic brain radionecrosis (grade \>=2 defined according to CTCAE scale v5.0).
Assess progression free survival (progression free survival = PFS) at 3 years
时间窗: up to 13 years
Percentage of patients alive and free of disease progression at 3 years after the start of radiotherapy (PFS rate). Progression will be defined as increase in size of treated lesions or appearance of new lesions (according to RANO meningioma criteria)
次要结局
- Overall survival (Overall survival = OS)(up to 13 years)
- Incidence of other toxicities(up to 13 years)
- Concordance between GTV-RM and GTV-PET(up to 13 years)