Contrast Enhanced Ultrasound in Neurosurgery to Improve Glioma Visualization and Border Demarcation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
This study plans to learn more about using contrast enhanced ultrasound (CEUS) in brain tumor surgery.
The goal of glioma brain tumor surgery is to remove as much of the glioma as possible. Tumor tissue that is close to normal brain tissue can look very similar. This can make it difficult for the surgeon to remove all the tumor. In this study, we hope to learn if using CEUS during brain tumor surgery will allow the brain surgeon to better see and remove all the tumor tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Able to sign and date the consent form
- •* Stated willingness to comply with all study procedures and be available for the duration of the study
- •* Be a male or female aged 18-95
- •* Have a planned standard of care surgery for presumed primary or known recurrent glioma
- •* WHO performance status \/= 70)
- •* Patient of childbearing potential must have a negative pregnancy test within 14 days of inclusion
排除标准
- •Patient at high risk of surgical site infection (e.g., 2 or more previous craniotomies/neurosurgery within the last 3 months, poor skin condition, and/or previously infected surgical field, or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)
- •Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in the contrast agent.
- •Patient with known or suspected active or chronic infections.
- •Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mm Hg), uncontrolled systemic hypertension, or adult respiratory distress syndrome.
- •Pregnant, or breastfeeding patient.
- •Patient with known sickle cell disease.
- •Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care.
- •Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision.
研究组 & 干预措施
Brain tumor surgery with Definity contrast and Contrast Enhanced Ultrasound
干预措施: Definity contrast during ultrasound (Combination Product)
结局指标
主要结局
Primary Objective
时间窗: Up to 3 days
This study plans to learn more about using contrast enhanced ultrasound (CEUS) to better identify normal brain from tumor in brain tumor surgery. The goal of brain tumor surgery is to remove as much of the tumor as possible. Tumor tissue that is close to normal brain tissue can look very similar. This can make it difficult for the surgeon to remove all the tumor. In this study, we hope to learn if using CEUS during brain tumor surgery will allow the brain surgeon to better see and remove all the tumor tissue. The ability of CEUS to improve visualization of brain tumor during surgery will be measured by the surgeon during surgery. The surgeon will also take images of the surgery site during surgery with the contrast enhanced ultrasound machine. These images will be studied later to determine if CEUS improves the surgeons ability to better visualize tumor during surgery.
次要结局
未报告次要终点