18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging
研究概览
简要总结
The goal of this clinical trial is to evaluate the performance characteristics of O-(2-[18F]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of [18F]FET-PET in delineating disease. The main question[s] it aims to answer are:
- whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression
- whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or Women, aged 21 years or older at time of screening
- •Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour
- •With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field
- •Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry
- •Subject must consent to undergo all study procedures
排除标准
- •Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17
- •Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.
- •Proven cerebral metastases
- •IDH-mutated gliomas
- •Pregnancy/ breast-feeding
研究组 & 干预措施
FET PET
Upon recruitment, a single study visit will be scheduled where subjects undergo a limited 18F-FET PET/CT of the brain in SGH.
After the study visit, from time of recruitment, they will continue their regular clinic visits as clinically indicated, where they will be monitored for at least a year for stability or deterioration. If clinically indicated, they may undergo conventional MRI, alternative MRI imaging and/or histopathological correlation in their respective primary institutions.
During these follow-up visits, any adverse effects possibly attributed to the 18F-FET PET/CT can also be flagged up.
Any alternative MRI imaging performed (as part of clinical practice in the respective primary institutions) within 4 weeks of the 18F-FET PET/CT study will also be included in the comparative analysis.
干预措施: FET PET (Diagnostic Test)
结局指标
主要结局
Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging
时间窗: 1 year
Sensitivity and specificity of \[18F\]FET-PET in delineating disease.
次要结局
未报告次要终点