Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Total sodium concentration
研究概览
简要总结
This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.
详细描述
PRIMARY OBJECTIVES:
I. Construct and test a novel multinuclear Na+-H+ metabolic MRI sequence with sensitivity to Sodium (Na+) concentration, Potential of Hydrogen (pH), and oxygen (O2).
II. Correlate Na+-, pH-, and O2-weighted MR image measurements with sodium-proton exchanger isoform-1 (NHE1) immunohistochemistry (IHC), bioenergetics, and gene expression using stereotactic image-guided biopsies from human brain tumors.
III. Quantify changes in Na+-, pH-, and O2-weighted MR images after neoadjuvant anti-PD-1 immunotherapy in recurrent glioblastoma (GBM) and explore associated changes in tumor biology.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •AIM 1: Healthy volunteers with no evidence of brain tumors or neurologic disease
- •AIM 1: Age 18+
- •AIM 2: Newly diagnosed or recurrent suspected or confirmed glioma (low or high grade)
- •AIM 2: 10 IDH mutant and 10 IDH wild type gliomas
- •AIM 2: Clinically indicated for resective surgery or biopsy
- •AIM 2: Age 18+
- •AIM 2: Tumor size > 1x1x1 cm (measurable)
- •AIM 3: Recurrent glioma enrolled in an immunotherapy trial or clinically indicated to receive immunotherapy including anti-PD1
- •AIM 3: Age 18+
排除标准
- •AIM 1: Cannot safely perform an MRI
- •AIM 1: Age < 18
- •AIM 2: Cannot safely perform an MRI or use of MRI contrast agents
- •AIM 2: Age < 18
- •AIM 3: Cannot safely perform an MRI or use of MRI contrast agents
- •AIM 3: Age < 18
结局指标
主要结局
Total sodium concentration
时间窗: Up to 5 years
Will calculate NaT using standard methodology and normalize it to ocular Na+ concentration, a constant 135 mmol/l. Will then test whether healthy tissue has a coefficient of variance (COV) of \< 10% across all 20 subjects.
NHE1 expression
时间窗: Up to 5 years
Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression.
Tumor metabolism
时间窗: Up to 5 years
Will examine the correlation between baseline tumor metabolism and change in metabolism with respect to overall survival using Cox multivariable regression.
次要结局
未报告次要终点