[18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI.
研究概览
简要总结
Characterize the cerebral distribution and [18F]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.
详细描述
Monocenter, open, uncontrolled and non-randomized pilot study designed to evaluate the uptake of [18F]-Fludarabine in 16 patients with newly diagnosed CNS lymphoma at initial diagnosis, before treatment using hybrid PET/MR system.
Main objective: to characterize the brain distribution and tumoral uptake in CNS lymphoma before treatment. The secondary objectives are to compare PET-[18F]-Fludarabine results with those of morphological MRI with and without gadolinium injection, diffusion and perfusion MRI, proton-spectroscopy, histological or cytological diagnosis, and brain [18F]-FDG PET imaging.
Patient screening includes a clinical and neurological examination, diagnostic MRI, biological examination, [18F]-FDG PET examination to exclude systemic lymphoma, histological/cytological diagnosis of brain lymphoma. Once informed consent is obtained, one brain PET with [18F]-Fludarabine (4 MBq/kg) combined with simultaneous multiparametric MR sequences is scheduled.
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 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years
- •Diagnosis of newly diagnosed high-grade CNS lymphoma (with histological and/or cytological confirmation)
- •Patient naive to chemotherapy, or radiotherapy treatment for CNS lymphoma
- •Contrast-enhanced intracranial mass greater than or equal to 1 cm longest axis
- •Karnofsky index ≥ 40
- •No systemic lymphoma on [18F]-FDG PET/CT
- •Creatinine clearance ≥ 30 mL/min
- •Social security affiliation (excluding AME)
- •Signature of the informed consent by the patient or by a legal representative or the close relative if the patient is not able to do so
排除标准
- •Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F]-Fludarabine
- •History of allergy to gadolinium chelates (DOTAREM®)
- •Absolute contraindication to MRI (pacemaker, cochlear implant ...), to the administration of gadolinium
- •Patient of childbearing potential without effective contraception, breastfeeding or pregnant
- •Severe cognitive impairment incompatible with good cooperation in the PET-MRI examination
- •Patient with pain or restlessness unable to remain motionless in supine position for 60 minutes
- •Weight > 100 Kg
- •Patient deprived of liberty or under legal protection (guardianship or curatorship)
- •Ongoing participation in another interventional research protocol. Participation in research of a non-interventional type is authorized
- •Traitement antérieur pour un lymphome primitif du système nerveux central
- •Isolated primary vitro-retinal lymphoma
- •Isolated CNS relapse of a systemic lymphoma
- •Other active cancer except basal cell carcinoma of the skin and/or cervical cancer in situ
- •Immunosuppression (organ transplant in particular)
- •Treatment with dipyridamole
- •Positive HIV serology
- •Presence of another progressive pathology that is life-threatening in the short term
结局指标
主要结局
Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI.
Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI.
次要结局
- lesion volumes in 3D T1 MRI with Gadolinium
- Tumor/healthy tissue contrast on PET-[18F]-Fludarabine
- Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG
- Cerebral distribution and activity-time curves for [18F]-Fludarabine
- Apparent diffusion coefficient (ADC) in diffusion MRI
- Tumor perfusion in perfusion MRI
- Metabolite ratios in spectroscopy
- histological or cytological diagnosis
研究者
Pr Aurélie KAS
Scientific
Assistance Publique Hopitaux De Paris