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临床试验/NCT03188354
NCT03188354已完成不适用

Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
1
主要终点
sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans

研究概览

简要总结

Primary central nervous system lymphoma (PCNSL) is a rare subtype of extranodal non-Hodgkins Lymphoma (NHL) with rising incidence and variable response to treatment. MRI is considered the most useful imaging modality of PCNSL, but conventional MRI has its limitations, and contrast-enhanced MRI sometimes does not clearly differentiate PCNSL from other neoplasm or non-neoplastic diseases.

Positron emission tomography (PET) could have a number of potential advantages in refining and improving the management of patients with PCNSL. Because of the rare incidence of PCNSL, the value of PET has however not been well defined in this subtype of lymphomas. There are a few studies that have investigated the role for FDG-PET and amino acid PET in the primary staging/diagnosis and response assessment in PCNSL patients, but the results are inconclusive. Further studies are therefore needed.

Previous studies support an integration of both MRI and PET for the routine diagnostic workup and response assessment for PCNSL, and the newly available simultaneous PET/MRI scanners may have the potential to improve imaging baseline accuracy, response assessment and add prognostic value in PCNSL.

The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI examination with the clinical routine MRI examination given to these patients today. It will be investigated whether PET (18F-FDG and 18F-fluciclovine) can provide additional prognostic value at baseline and in response assessment compared to MRI and established pre-treatment prognostic scores in PCNSL, and evaluate which PET/MRI parameters that are best suited as an imaging biomarker for progression-free survival.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histological diagnosis of PCNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy
  • Written informed consent from patient or guardian
  • Immunocompetent

排除标准

  • Previous chemotherapy
  • Contra-indications for MRI (Pacemakers, defibrillators, aneurysm clips, any form of metal in the body, or severe claustrophobia)
  • Hypersensitivity to either 18F-Fluciclovine or 18F-FDG or to any of the excipients
  • Pregnancy (pregnancy test for all women in fertile age)
  • Breastfeeding
  • Weight > 120 kg
  • Estimated glomerular filtration rate (eGFR) <30ml/min/1,73m2
  • HIV-positive

结局指标

主要结局

sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans

时间窗: 2 days

of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination

sensitivity and specificity of 18F-FDG-PET/MRI scans

时间窗: 2 days

of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination

次要结局

  • prediction of progression-free survival(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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