The Evaluation of D-glucose Weighted Chemical Exchange Saturation Transfer (gluceoCEST)-Based Dynamic Glucose Enhanced(DGE) Magnetic Resonance Imaging（MRI） in Brain Tumor
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema
研究概览
简要总结
Recently, natural D-glucose was suggested as a potential biodegradable contrast agent. The feasibility of using D-glucose for dynamic perfusion imaging was explored to detect malignant brain tumors based on blood brain barrier breakdown. Our study try to evaluate the feasibility of dynamic glucose enhanced(DGE) magnetic resonance imaging（MRI）in brain tumor, which based on D-glucose weighted chemical exchange saturation transfer (gluceoCEST).
详细描述
methods： Brain tumor patients were recruited. Time-resolved glucose signal changes were detected using chemical exchange saturation transfer (glucoCEST) MRI. Dynamic glucose enhanced (DGE) MRI was used to measure tissue response to an intravenous bolus of D-glucose. During the dynamic glucose scan, a brief hyperglycemic state was established by intravenous infusion of hospital-grade D50 glucose (D50, 25 g of dextrose in 50 mL of water sterile solution), followed by 20 mL of saline solution in 1 arm. The glucose infusion was performed using a power injector at an infusion rate of 0.2 mL/s, corresponding to total infusion times of 250 seconds. Performing contrast enhancement based on Gd-DTPA in 30 minutes later, which was used for comparison as golden standard.
The area of hyperintensity will be measured, which represents the area of brain tumor.
Differential test and Consistency analysis were used for statistical analysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have a brain mass consistent with a primary brain tumor or metastatic brain tumor
- •able to give consent and willingness to participate in this study.
排除标准
- •presence of any ferromagnetic implant (cardiac pacemakers, aneurysm clip, etc.)
- •pregnancy
- •claustrophobia or anxiety disorder
- •history of vertigo
- •persons with diabetes mellitus (self-report or HbA1C >= 6.5%)
- •Sickle cell disease
- •persons taking prescription medicine for hypertension
- •blood iron deficiency (Hb concentration < 11 g/dL or Hct < 32%)
- •If volunteering for MRI: history of kidney disease and/or eGFR <
- •Middle-ear disorder
- •double vision
- •Seizure disorder
- •Multiple myeloma
- •Solid organ transplant
- •History of severe hepatic disease/liver transplant/pending liver transplant
研究组 & 干预措施
D-glucose
During the dynamic glucose scan, a brief hyperglycemic state was established by intravenous infusion of hospital-grade D50 glucose (D50, 25 g of dextrose in 50 mL of water sterile solution), followed by 20 mL of saline solution in 1 arm. The glucose infusion was performed using a power injector at an infusion rate of 0.2 mL/s, corresponding to total infusion times 250 seconds.
干预措施: d-glucose (Drug)
结局指标
主要结局
CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema
时间窗: 1 week
the CEST value of tumor core and necrosis might higher than white matter
次要结局
未报告次要终点