Phase 2 Study on Brain Tumor Uptake of the Amino Acid O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Histological samples where available
研究概览
简要总结
The purpose of this study is to determine the uptake of the amino acid O-(2-[F-18]Fluorethyl)-L-tyrosin (FET) in human brain tumors using positron emission tomography. A comparison to MRI and histopathological samples is used.
详细描述
Radioactively labelled amino acids have been used for years to delineate primary brain tumors and for the early detection of tumor recurrence. Positron emission tomography studies indicate that the extent of amino acid uptake correlates to the true histological extent of gliomas. Recently a fluorine-18 labelled amino acid has been introduced (O-(2-[F-18]Fluorethyl)-L-tyrosin (FET)), which is suitable for routine use in brain tumor patients. There is evidence that this amino acid is transported into brain and brain tumors by the amino acid transport of the L-type. The cDNA of this L-transporter has recently been cloned and has been shown to be identical to the light chain of the 4F2-antigen (CD98), which has previously been described as marker of cell growth and proliferation.
The heavy chain of this heterodimer is known to modulate integrins which are thought to play a fundamental role in glioma invasion.
Besides the evaluation of the diagnostic capability of FET in brain tumors, a comparison of FET uptake in vivo and CD98 expression ex-vivo is performed with tissue slices as available after routine surgery in glioma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected primary brain tumors
- •CT or MRI showing lesion of >= 2,5 cm
- •Any age; parents informed consent in children available
- •Karnofsky-Index >= 20 %
- •Referral by Depts. of Neurology, Neuro-Oncology, Neurosurgery, or Pediatric Neurology at the UKM
- •Biopsy and/or surgery planned
- •Patient is able to lie during the PET scan for 50 minutes without moving • Patient must be able to give informed consent; signature must be present before the PET scan
排除标准
- •Pregnancy or breast feeing
- •Patients, who by psychiatric disease are not able to give informed consent
- •Complete renal failure
- •Inclusion to other studies according to § 23 of the German radiation protection law
结局指标
主要结局
Histological samples where available
CD98 staining where available
次要结局
- Clinical follow-up for at least one year