Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intra- and post-operative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.
详细描述
PRIMARY OBJECTIVE:
I. Determine biomarkers of in situ gliomas across a diverse patient cohort using intra- or post-operative microdialysis to sample extracellular metabolites and other analytes.
SECONDARY OBJECTIVE:
I. Evaluate the yield and specificity of microdialysate D-2HG as a candidate tumor biomarker to differentiate between IDH-mutated and IDH-wildtype gliomas.
II. Identify biomarkers of tumor-associated processes including brain edema, brain infiltration with non-enhancing tumor, and tumor-associated hypoxia or necrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Age >= 18 years
- •Diagnosis of the following, based on clinical and radiographic evidence:
- •Any glioma
- •Metastatic brain tumor of any primary origin
- •Epileptic focus requiring surgical resection
- •Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor (primary or metastatic) or epileptic focus as part of routine clinical care
- •Willing to undergo neurosurgical resection or biopsy at Mayo Clinic [Rochester, Minnesota (MN)]
- •For patients with gliomas recruited for post-operative microdialysis, willingness to stay in the hospital through post-operative day (POD) 3-5 (timing per physician and patient's shared decision making)
- •Ability to understand and the willingness to sign a written informed consent document
- •Enrollment into the Biobank study (IRB#12-003458)
排除标准
- •Vulnerable populations: pregnant women, prisoners or the mentally handicapped
- •Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness
研究组 & 干预措施
Cohort I (intra-operative microdialysis)
Patients undergo microdialysis over 15 minutes during standard of care biopsy or resection. Patients also undergo MRI during screening and may undergo MRI on study.
干预措施: Microdialysis (Procedure)
Cohort I (intra-operative microdialysis)
Patients undergo microdialysis over 15 minutes during standard of care biopsy or resection. Patients also undergo MRI during screening and may undergo MRI on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort II (post-operative microdialysis)
Patients undergo microdialysis over 15 minutes after standard of care biopsy or resection. Patients also undergo MRI and CT on study.
干预措施: Microdialysis (Procedure)
Cohort II (post-operative microdialysis)
Patients undergo microdialysis over 15 minutes after standard of care biopsy or resection. Patients also undergo MRI and CT on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort II (post-operative microdialysis)
Patients undergo microdialysis over 15 minutes after standard of care biopsy or resection. Patients also undergo MRI and CT on study.
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 42 days
Will be assessed by evaluating the proportion of patients who: (2) develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of microdialysate catheters. Attribution of neurologic deficit will typically be considered unlikely unless there is evidence of intra-operative intracranial hemorrhage that the surgeon deems to be attributable to use of the microdialysis catheter. Adverse events will be measured by Common Terminology Criteria for Adverse Events 5.0.
Targeted metabolomics
时间窗: Up to 42 days
Metabolites within each region of tumor to brain-adjacent-to tumor within a patient compared. Metabolites from patients without central nervous system malignancies averaged across the epileptic foci group and descriptively compared to the areas from patients with gliomas.
次要结局
- Microdialysate D-2HG(Up to 42 days)
- Non-enhancing (FLAIR)- region metabolites(Up to 42 days)
- Necrotic core metabolites(Up to 42 days)
- Microdialysate D-2HG(Up to 42 days)
- Non-enhancing (FLAIR)- region metabolites(Up to 42 days)
- Necrotic core metabolites(Up to 42 days)