Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of Ommaya reservoir placement
研究概览
简要总结
This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.
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
- 否
入选标准
- •Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
- •Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic (Rochester, Minnesota [MN])
- •Willingness of the patient to provide informed consent
- •Patient is willing to have their Ommaya sampled on at least 2 future occasions
- •Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)
排除标准
- •Vulnerable populations including pregnant women, prisoners, and individuals < 18 years old
- •Patients who are not appropriate candidates for biopsy due to current or past medical history or uncontrolled current illness
- •Prior history of any wound infection
- •Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may include, but will not be limited to, surgical anatomy, clinical evidence of immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns
研究组 & 干预措施
Ommaya reservoir placement
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.
干预措施: Biospecimen Collection (Procedure)
Ommaya reservoir placement
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.
干预措施: Intracranial Catheter Placement (Procedure)
Ommaya reservoir placement
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.
干预措施: Lumbar Puncture (Procedure)
Ommaya reservoir placement
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.
干预措施: Biopsy (Procedure)
Ommaya reservoir placement
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.
干预措施: Computed Tomography (Procedure)
Ommaya reservoir placement
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Feasibility of Ommaya reservoir placement
时间窗: Up to 5 years
Will be assessed based on the percent of patients for whom an Ommaya reservoir is successfully placed at the time of tissue biopsy without attributable complication.
次要结局
- Utility of Ommaya reservoir(Up to 5 years)