FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy (IMAGG)
(18F)-Fluoroethyl-L-tyrosine Positron Emission Tomography and Multiparametric MRI for the Delination of Target Volumes in High-grade Glioma Patients Undergoing Radiotherapy
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Brest、法国、29609
- 招聘中
- CHRU de Brest
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
- WHO ≤ 2
- Indication for adjuvant radiotherapy
- Surgery must have been performed 45 days before the start of radiotherapy.
- Ability to understand and to give consent
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images
大体时间:12 months
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Increase in at least 10% of irradiation target volumes compared to the result of the MRI+scanner reference technique.
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment failure pattern in respect to the target volume based on standard MRI, multiparametric MRI and FET-PET.
大体时间:12 months
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Irradiation target volumes associated with standard MRI
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12 months
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Sites of failures with composite and standard MRI based RT planning
大体时间:12 months
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Irradiation target volumes associated with standard MRI based RT planning
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12 months
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无进展生存期
大体时间:12个月
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12个月
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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