Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Progression free survival calculated from the date of completion of the end of chemotherapy PET
研究概览
简要总结
Patients older than 60 years account for half of cases of Primary Central Nervous System Lymphoma (PCNSL) and have a poorer outcome. No prognostic or predictive factors exist for survival after initial remission. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - Positron Emission Tomography ([18F]FDG-PET) plays a key role in grading and therapy monitoring of systemic diffuse large B-cell type.
LOCALYZE is an ancillary Positron Emission Tomography / Magnetic Resonance (PET/MR) clinical study from BLOCAGE 01 (Pr Hoang-Xuan). The aim is to evaluate the usefulness of [18F]FDG-PET to monitor treatment response in PCNSL older than 60 years (n=56), in complement to multiparametric Magnetic Resonance Imaging (MRI).
Hypothesis The investigators assume that the development of new imaging biomarker extracted from PET imaging and multiparametric MRI, could improve the assessment of treatment response in PCNSL.
详细描述
[18F]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital:
- prior to initiation of chemotherapy (rituximab, methotrexate, procarbazine, vincristine and cytarabine) (PET#1),
- after two chemotherapy cycles (PET#2),
- at the end of the first-line chemotherapy regimens (PET#3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed primary cerebral lymphoma
- •Age ≥60 years
- •Pathology proven diagnosis or positive cytology of the Cerebrospinal Fluid (CSF) or vitreous
- •Karnofsky Performance Status ≥40
- •No evidence of systemic Non-Hodgkin lymphomas (NHL) (body CT scan, bone marrow biopsy)
- •Adequate haematological, renal and hepatic function
- •Calculated creatinine clearance > 40 ml/min
排除标准
- •Uncontrolled diabetes with fasting glycaemia > 200 mg/dL
- •Sensitivity to active substance in [18F]-FDG
- •Calculated creatinine clearance < 40 ml/min
- •No contraindication to MRI (magnetic resonance imaging)
结局指标
主要结局
Progression free survival calculated from the date of completion of the end of chemotherapy PET
时间窗: 6 months
To evaluate the predictive value of \[18F\]FDG-PET assessment performed at the end-of-treatment (high-dose methotrexate based polychemotherapy), on progression free survival in newly diagnosed PCNSL with age ≥60 years (n=56).
次要结局
未报告次要终点