Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- PET/CT vs histopathological diagnosis
研究概览
简要总结
The aim of this study was to analyse usefulness of [68Ga]Ga-PSMA-11 PET/CT scans in preoperative differentiation between HGG and LGG in patients with suspicion of a tumor of glial origin in previously performed imaging examinations. The PET/CT scan will be compared with postoperative histopathological results and with additional immunohistochemical staining for PSMA expression.
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
- 否
入选标准
- •primary lesion found in CT/MRI with radiological features of glial neoplasm
- •untreated disease, planned surgery
- •negative medical history of other neoplastic diseases
- •age over 18
- •informed, voluntary consent to participate in the study
排除标准
- •pregnant women, breastfeeding women
- •persons with a known allergy to PSMA
- •age under 18
- •patient's lack of cooperation
结局指标
主要结局
PET/CT vs histopathological diagnosis
时间窗: through study completion, an average of 1.5 year
Comparison of the incidence of positive preoperative \[68Ga\]Ga-PSMA-11 PET/CT results with the final histopathological diagnosis based on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021). The PET scan in this regard will be evaluated qualitatively - in terms of finding accumulation in the projection of the brain tumor (positive result) and lack of accumulation in the projection of the brain tumor (negative result). The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype
次要结局
- PET/CT semiquantitive parameter - TBR vs histopathological diagnosis(through study completion, an average of 1.5 year)
- PET/CT semiquantitive parameter - SUVmax vs immunohistopathological staining(through study completion, an average of 1.5 year)
- PET/CT semiquantitive parameter - SUVmax vs progession free survival time.(1 year after the study)
- PET/CT semiquantitive parameter - SUVmax vs overall survival time.(1 year after the study)
- PET/CT semiquantitive parameter SUVmean vs histopathological diagnosis(through study completion, an average of 1.5 year)
- PET/CT semiquantitive parameter - TLR vs histopathological diagnosis(through study completion, an average of 1.5 year)
- PET/CT vs overall survival time.(1 year after the study)
- PET/CT semiquantitive parameter - SUVmax vs histopathological diagnosis(through study completion, an average of 1.5 year)
- PET/CT vs progession free survival time.(1 year after the study)