Pilot Study of 11C-Choline (11C-CH) PET in Assessing Post-treatment True Tumor Progression From Pseudo-progression in High-grade Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- SUV Measures
研究概览
简要总结
This is a pilot study. The purpose of this study is to test if an imaging tracer, not approved by the FDA, called 11C-Choline (11C-CH) is useful for evaluating your type of cancer. This tracer is used to perform PET scans. The researchers want to see if the 11C-CH PET scan, using the study tracer 11C-CH, can improve upon the usual scans at diagnosing or monitoring your type of cancer.
In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It is important to distinguish true tumor growth from inflammation since inflammation indicates the tumor is responding to treatment. With standard MRI, it is difficult to determine if changes following treatment are due to tumor growth or inflammation early on. Researchers hope to learn if the investigational tracer, 11C-CH, will be able to distinguish true tumor growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient is able to provide written informed consent prior to study registration
- •Histologically-confirmed high-grade glioma
- •Completion of treatment with standard radiation (with or without concurrent therapy).
- •Standard gadolinium-enhanced MRI changes that are considered indeterminate for tumor progression vs. treatment-related changes by the neuroradiologist or clinician within 24 weeks of completion of radiation.
排除标准
- •Inability to undergo or cooperate with an MRI or PET scan (e.g., claustrophobia, metal implant)
- •Renal insufficiency with recent (<3 month old) creatinine > 2.0 mg/dL
- •Pregnant or nursing female
结局指标
主要结局
SUV Measures
时间窗: 1 year
from 11C-CH PET with evolving changes on brain MRI in high-grade glioma after radiotherapy. In a small subgroup of patients required surgery, tissue will be analyzed for histopathologic correlate. The data gathered will not be considered definitive, but rather will be used to as preliminary data in support of a larger, definitive study.
次要结局
未报告次要终点