NCT01248754已完成2 期
A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection
Alan Nichol3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.
研究概览
简要总结
The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Contrast-enhancing mass on diagnostic brain CT or MRI strongly suggesting a diagnosis of WHO grade III or IV glioma
- •Karnofsky Performance status (KPS) ≥ 70
- •Age ≥18 years
- •Subject is able to understand and consent to study
- •Glomerular filtration rate (GFR) ≥ 45 ml/minute
排除标准
- •Indication for urgent craniotomy to relieve mass effect
- •Only stereotactic biopsy indicated because tumour is located in eloquent brain.
- •The enhancement on the T1 MRI sequence involves or abuts the basal ganglia
- •Previous intracranial malignancy or any invasive malignancy unless free of disease > 5 years
- •Prior cranial irradiation
- •Contra-indications to systemic radiation exposure: pregnancy or breast feeding
- •Subject exceeds the weight limit of the PET scanner bed (204.5 kg)
- •Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease
- •Allergies or other contraindication to CT contrast or MRI contrast
研究组 & 干预措施
18F-DOPA PET imaging
Experimental
Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection.
干预措施: Surgical neuronavigation with 18F-DOPA PET imaging (Procedure)
结局指标
主要结局
The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.
时间窗: Less than 72 hours postoperatively
次要结局
未报告次要终点
研究者
Alan Nichol
Radiation Oncologist
British Columbia Cancer Agency
研究点 (3)
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