68Ga-citrate PET/MR Imaging for the Evaluation of Glioma in Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Susan Chang
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Maximum standardized uptake value (SUVmax)
研究概览
简要总结
This is a prospective, single center, open-label study in adult patients with presumed World Health Organization (WHO) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate Positron Emission Tomography / magnetic resonance (PET/MR) prior to surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •World Health Organization (WHO) grade 3 or 4 glioma planning to undergo surgery
- •Age >= 18 yrs.
- •Karnofsky performance status of >= 60
- •Ability to understand a written informed consent document, and the willingness to sign it.
- •Positive for Phosphatase and Tensin Homolog (PTEN) deletion, confirmed by immunohistochemistry of tissue biopsy
- •Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy
排除标准
- •Contraindications to Positron Emission Tomography (PET) imaging (e.g. pregnant or breast-feeding woman)
- •Contraindications to magnetic resonance (MR) imaging (e.g. pacemakers, metallic implants, etc.)
研究组 & 干预措施
Positive for PTEN deletion
Confirmed by immunohistochemistry of tissue biopsy
干预措施: 68Ga-citrate PET/MR (Drug)
Negative for PTEN deletion
Confirmed by immunohistochemistry of tissue biopsy
干预措施: 68Ga-citrate PET/MR (Drug)
结局指标
主要结局
Maximum standardized uptake value (SUVmax)
时间窗: 1 day
The location and extent of 68Ga-citrate uptake will be compared to both same day magnetic resonance imaging (MRI) and subsequent pathology. SUVmax will be the outcome of interest and summarized with descriptive measures. SUVmax will be compared via a two-sided two-sample equal-variance t-test between those patients positive for PTEN deletion and those negative for PTEN deletion.
次要结局
未报告次要终点
研究者
Susan Chang
Principal Investigator
University of California, San Francisco