NCT01138813已完成不适用
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue
研究概览
简要总结
This study will evaluate the test-retest repeatability of lactate and other metabolites measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients radiographically diagnosed with glioma.
These measurements will test whether the concentration of lactate in tumor will be higher than the concentration of lactate in normal tissue of the same patient.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher which is > 3cm in diameter based on radiographic examination
- •Patients about to receive biopsy or resection of newly diagnosed glioma
排除标准
- •Contraindication to magnetic resonance imaging (MRI): e.g. cardiac pacemaker, metallic implants, known contrast allergy, and pregnancy
- •Impaired renal function
- •Current or previous chemotherapy, radiation, or other tumor treatment excluding steroids
- •Tumor location extra-cerebral, temporal, or in close proximity to frontal sinus
结局指标
主要结局
The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue
时间窗: 90 minutes
The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS
时间窗: 90 minutes
次要结局
- True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values(90 minutes)
- The mean levels of each of the metabolites will be summarized by tumor grade and type(90 minutes)
- The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors(90 minutes)
- The geometric mean fold rise (GMFR) in the concentrations of lactate and each of the other metabolites for tumor/normal tissue(90 minutes)
- The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue(90 minutes)
- The within day and between day standard deviations for each metabolite(90 minutes)
研究者
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