18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Suspicious Lesions Identified by 18F FDOPA PET
研究概览
简要总结
To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.
详细描述
This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 15 year-old at the time of radiotracer administration
- •Provides written informed consent
- •Suspected new diagnosis or suspected recurrence of glioma
- •Able to remain still for duration of each imaging procedure (about 20 minutes)
排除标准
- •Less than 15 year-old at the time of radiotracer administra
- •Unable to provide informed consent
- •Inability to lie still for the entire imaging time
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
研究组 & 干预措施
Diagnostic (FDOPA-PET/CT or PET/MRI)
Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.
干预措施: 18F-fluoro-dihydroxyphenylalanine (Drug)
Diagnostic (FDOPA-PET/CT or PET/MRI)
Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.
干预措施: Positron emission tomography (PET) (Procedure)
Diagnostic (FDOPA-PET/CT or PET/MRI)
Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.
干预措施: Computed tomography (CT) (Procedure)
Diagnostic (FDOPA-PET/CT or PET/MRI)
Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.
干预措施: Magnetic resonance imaging (Procedure)
结局指标
主要结局
Number of Suspicious Lesions Identified by 18F FDOPA PET
时间窗: Up to 30 minutes after injection of F18 FDOPA
The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.
Percent Agreement of 18F FDOPA PET With Pathology
时间窗: Up to 30 minutes post-injection (at time of scan)
For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.
次要结局
未报告次要终点
研究者
Erik Mittra
Clinical Assistant Professor
Stanford University