(18F)-Fluoroethyl-L-tyrosine Positron Emission Tomography and Multiparametric MRI for the Delination of Target Volumes in High-grade Glioma Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images
研究概览
简要总结
Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema.
To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 Years or older
- •Histologically confirmed newly diagnosed glioblastoma or anaplastic astrocytoma
- •Patients must have undergone surgery with macroscopic complete resection or incomplete resection with residual disease less than 5 cm on MRI
- •An MRI or a scan 48h after surgery should be available
- •Indication for adjuvant radiotherapy
- •Surgery must have been performed 45 days before the start of radiotherapy.
- •Ability to understand and to give consent
排除标准
- •Age < 18 Years.
- •Prior radiation therapy to the brain
- •Any usual formal indication against MRI (claustrophobia, metallic objects or implanted medical devices in body: pacemaker, clips, prostheses ...)
- •Allergic reaction to FET
- •Pregnant women or nursing mothers
- •Refusal to use effective contraception at study entry and throughout the study if patient is of childbearing age.
结局指标
主要结局
Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images
时间窗: 12 months
Increase in at least 10% of irradiation target volumes compared to the result of the MRI+scanner reference technique.
次要结局
- Progression-free Survival(12 months)
- Treatment failure pattern in respect to the target volume based on standard MRI, multiparametric MRI and FET-PET.(12 months)
- Sites of failures with composite and standard MRI based RT planning(12 months)