Use of Shear Wave Elastography for Intraoperative Brain and Tumor Stiffness Measurements
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.
研究概览
简要总结
This study investigates the role of intraoperative shear wave elastography ultrasound (ISWEU) in identifying healthy brain and tumor tissue stiffness differences. This data may be used to guide tumor resection in future patients.
详细描述
PRIMARY OBJECTIVE:
I. Determine the feasibility of utilizing ISWEU measurements intraoperatively and in the human brain to measure tissue stiffness.
OUTLINE: This is an observational study.
Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Patients must be at least 18 years old.
- •Patients must have planned surgery for resection of a newly diagnosed or recurrent brain tumors.
- •Patients with tumors located in the brain cortex or superficial white matter in which introduction of the ultrasound probe is straightforward and does not pose a risk for intraoperative complications.
- •Patients must have a Karnofsky performance status ≥ 60%.
- •Patient or legally authorized representative (LAR) willing to provide written informed consent.
排除标准
- •Patients with deep-seated brain tumors in which introduction of the ultrasound probe poses an increased risk.
- •Patients with a history of any brain infections.
- •Patients with implanted devices.
- •Patients with any other neurological/neurosurgical disease that could affect tissue stiffness.
- •Patients with any other structural brain defect that could affect tissue stiffness.
研究组 & 干预措施
Observational
Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.
时间窗: At baseline
After intraoperative measurement of brain stiffness using ISWEU, analysis will be conducted after each procedure by determining the tissue stiffness from different areas (tumor core, peritumoral brain zone, and non-cancerous brain tissue) and comparing the tumor stiffness between patients. Reviewers will determine whether ISWEU is feasible to be used as a tool to influence surgical decision.
Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.
时间窗: At baseline
After intraoperative measurement of brain stiffness using ISWEU, analysis will be conducted after each procedure by determining the tissue stiffness from different areas (tumor core, peritumoral brain zone, and non-cancerous brain tissue) and comparing the tumor stiffness between patients. Reviewers will determine whether ISWEU is feasible to be used as a tool to influence surgical decision.
次要结局
未报告次要终点