Dual Time Point FDG PET Imaging Optimization for the Evaluation of Glioblastoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Differences in length-beam ratio
研究概览
简要总结
This early phase I trial studies the how well fluorodeoxyglucose F-18 (FDG) positron emission tomography (PET) imaging works in diagnosing patients with confirmed or suspected glioblastoma. Diagnostic procedures, such as FDG PET, may help find and diagnose glioblastoma.
详细描述
PRIMARY OBJECTIVES:
I. To assess the optimal FDG positron emission tomography (PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients with glioblastoma.
SECONDARY OBJECTIVES:
I. To identify genotypic factors in FDG tumor metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), mean tumor volume (MTV) and L/B ratio.
EXPLORATORY OBJECTIVES:
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (> 19 years of age) patients with biopsy proven (as opposed to being status post definitive surgical therapy) or highly suspected glioblastoma of the brain
- •Cases without prior biopsy will be chosen based upon consensus of a MD Anderson faculty neuroradiologist and neurosurgeon for high probability of representing a glioblastoma
- •T1 post contrast lesion size greater than or equal to 10 mm
排除标准
- •Definitive/gross total lesion resection
- •Prior brain cancer
- •Prior whole brain radiation
- •Known history of cerebrovascular disease, dementia or prior non-mild traumatic brain injury
- •Known allergy to FDG or gadolinium based contrast agents
- •Pregnant women are excluded
结局指标
主要结局
Differences in length-beam ratio
时间窗: Up to 2 years
Will be tested via paired t-test after appropriate transformation.
Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling
时间窗: Up to 2 years
Will be derived from magnetic resonance advanced brain tumor imaging.
Magnetic resonance images of relative blood volume, blood flow, apparent diffusion coefficient and forward volumetric transfer constant
时间窗: Up to 2 years
Will be used to derive quantitative parametric maps based on biophysical principles or pharmacokinetic modeling.
Fluorodeoxyglucose F-18 uptake patterns
时间窗: Up to 2 years
Will be correlated with magnetic resonance images.
Genotypic factors
时间窗: Up to 2 years
Will be assessed via two-sample t-tests, for all genes of interest with at least 20% of mutation prevalence.
次要结局
未报告次要终点