NCT04566185已完成不适用
Evaluation of the Value of 18F-fluorodeoxyglucose Positron Emission Tomography (FDG PET) and Brain Perfusion Computed Tomography (CT Perfusion) for Predicting the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Patients With Recurrent Glioblastoma
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Categorization of patients as responders or non-responders to treatment
研究概览
简要总结
In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient has an WHO score ≤ 3
- •The patient's estimated life expectancy is more than 3 months.
- •Patient with histologically proven diagnosis of glioblastoma.
- •Patient presenting with tumor progression on morphological MRI confirmed by a multidisciplinary committee.
- •Patient with a unilateral supratentorial target lesion upon inclusion to establish a tumor region of interest (ROI) zone and an equivalent ROI zone in contralateral healthy tissue.
- •Patient progressing after radiotherapy and at least one line of chemotherapy with TEMODAL
- •Patient in whom treatment with Bevacizumab monotherapy has been validated by a multidisciplinary committee.
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Pregnant or breast feeding patients
- •Hypersensitivity to iodinated contrast media and creatinine clearance less than 60 ml / minute.
结局指标
主要结局
Categorization of patients as responders or non-responders to treatment
时间窗: 2 months
Measured by MRI according to Response Assessment in Neuro-Oncology (RANO) criteria: Complete response/Partial response/stable/progression
次要结局
- Fixation Index(Day 14)
- cerebral blood flow(Day 14)
- Normalized permeability-surface area product to healthy brain(Day 14)
- Inter-rater reproducibility of CT scan(End of study (September 2022))
- Metabolic Tumor Volume(Day 14)
- Normalized cerebral blood flow to healthy brain(Day 14)
- Inter-rater reproducibility of FDG PET(End of study (September 2022))
- permeability-surface area product(Day 14)
研究者
研究点 (2)
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