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 Nichol6 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7月最近更新:
适应症
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
- 6
- 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
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 (6)
Loading locations...
相似试验
进行中（未招募）
不适用
[18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain BiopsyGliomaNCT04870580University College, London21
进行中（未招募）
早期 1 期
18F-Fluorodopamine PET Studies of Neuroblastoma and PheochromocytomaPheochromocytomaNeuroblastomaNCT03541720St. Jude Children's Research Hospital13
撤回
不适用
[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in ChildrenBrain TumorsNCT00556153Children's Hospital Medical Center, Cincinnati
终止
不适用
18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent GliomasAdult Anaplastic EpendymomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Diffuse AstrocytomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Mixed GliomaAdult OligodendrogliomaAdult Pilocytic AstrocytomaAdult Pineal Gland AstrocytomaAdult Subependymal Giant Cell AstrocytomaChildhood High-grade Cerebellar AstrocytomaChildhood High-grade Cerebral AstrocytomaChildhood Low-grade Cerebellar AstrocytomaChildhood Low-grade Cerebral AstrocytomaRecurrent Adult Brain TumorRecurrent Childhood Anaplastic AstrocytomaRecurrent Childhood Anaplastic OligoastrocytomaRecurrent Childhood Anaplastic OligodendrogliomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood Diffuse AstrocytomaRecurrent Childhood Fibrillary AstrocytomaRecurrent Childhood Gemistocytic AstrocytomaRecurrent Childhood Giant Cell GlioblastomaRecurrent Childhood GlioblastomaRecurrent Childhood Gliomatosis CerebriRecurrent Childhood GliosarcomaRecurrent Childhood OligoastrocytomaRecurrent Childhood OligodendrogliomaRecurrent Childhood Pilomyxoid AstrocytomaRecurrent Childhood Protoplasmic AstrocytomaRecurrent Childhood Subependymal Giant Cell AstrocytomaRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Childhood Visual Pathway GliomaUntreated Childhood Anaplastic AstrocytomaUntreated Childhood Anaplastic OligoastrocytomaUntreated Childhood Anaplastic OligodendrogliomaUntreated Childhood Brain Stem GliomaUntreated Childhood Cerebellar AstrocytomaUntreated Childhood Cerebral AstrocytomaUntreated Childhood Diffuse AstrocytomaUntreated Childhood Fibrillary AstrocytomaUntreated Childhood Gemistocytic AstrocytomaUntreated Childhood Giant Cell GlioblastomaUntreated Childhood GlioblastomaUntreated Childhood Gliomatosis CerebriUntreated Childhood GliosarcomaUntreated Childhood OligoastrocytomaUntreated Childhood OligodendrogliomaUntreated Childhood Pilomyxoid AstrocytomaUntreated Childhood Protoplasmic AstrocytomaUntreated Childhood Subependymal Giant Cell AstrocytomaUntreated Childhood Visual Pathway and Hypothalamic GliomaUntreated Childhood Visual Pathway GliomaNCT02175745Erik Mittra2
已完成
不适用
18F-DOPA-PET in Non-tumoral and Tumoral Brain LesionsBrain TumorNCT04306484Centre Hospitalier Universitaire de Nīmes74