Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percent of Tumor Resected: Intracranial Lesions
研究概览
简要总结
Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors.
详细描述
This study will be a prospective non-randomized cohort study with patients presenting to Children's Hospital Colorado for resection of a central nervous system tumor. This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. Fluorescein sodium is a small organic salt that accumulates in areas of diminished blood-brain barrier integrity and allows for determination of the margins between tumor and normal brain function.
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
盲法说明
Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.
入排标准
- 年龄范围
- 31 Days 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 31 days through 21 years on date of surgery
- •Undergoing resection of a central nervous system tumor at Children's Hospital Colorado
- •Parent/legal guardian (or adult subject) willing and able to complete the informed consent process
排除标准
- •Tumor in functionally eloquent cortex that precludes maximal surgical resection
- •Severe renal dysfunction
- •Preoperative serum creatinine level > than normal range and GFR <
- •Severe liver dysfunction
- •History of asthma or pulmonary spasm
- •Known allergy to sodium fluorescein or any other contrast dye
- •Previous administration of sodium fluorescein within the last 72 hours
- •Pregnant or nursing mother
- •Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.
研究组 & 干预措施
Sodium-Fluorescein Resection
This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.
干预措施: Sodium Fluorescein (Drug)
Sodium-Fluorescein Resection
This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.
干预措施: Microscopic Resection (Device)
结局指标
主要结局
Percent of Tumor Resected: Intracranial Lesions
时间窗: Pre-op assessment to outpatient follow up, up to 6 weeks
For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In intracranial lesions, the use of volumetric imaging tools will be used to calculate the extent of tumor resection.
Percent of Tumor Resected: Spinal Lesions
时间窗: Pre-op assessment to outpatient follow up, up to 6 weeks
For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In spinal lesions, manual measurement will be used to determine the extent of resection.
次要结局
未报告次要终点