Mapping Draining Lymph Nodes in CNS Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes
研究概览
简要总结
The purpose of this research study is to determine whether the lymph nodes that drain a brain tumor can be detected by imaging after injection of a substance called Tc-99m tilmanocept directly into the brain tissue around the tumor. Tc-99m tilmanocept is a radioactive substance that is used to find lymph nodes by injecting it and then scanning the body with a device that can trace its radioactivity. In this study, the investigators are looking to see how long it takes the Tc-99m tilmanocept to travel from the tumor to the lymph nodes. The investigators will be using it to map lymph nodes as they relate to specific brain areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Candidate for surgical resection or stereotactic biopsy of suspected brain tumor, including benign tumors (e.g., meningioma) and malignant tumors (e.g., glioma or metastatic disease).
- •Suitable candidate to receive Tc-99m tilmanocept injection and study related imaging post-operatively per the Principal Investigator and/or treating neurosurgeon.
- •At least 18 years of age.
- •Willing and able to provide informed consent (or consent of legally authorized representative).
排除标准
- •Documented hypersensitivity to dextran and/or modified forms of dextran.
- •Pregnant.
- •Prior surgical evacuation of lymph nodes of the head and/or neck
研究组 & 干预措施
Cohort 1: Tc-99m tilmanocept
- The surgeon will inject up to 0.5 mL of reconstituted Tc-99m tilmanocept using a blunt tipped needle 1 cm into the wall of the resection cavity after completing surgical resection of the tumor
- Portable planar imaging will be obtained at 4.5 ± 2.5 hours and 24 +/- 8 hours after injection of Tc-99m tilmanocept.
干预措施: Tc-99m tilmanocept (Drug)
Cohort 2A: Tc-99m tilmanocept frontal lobe injection site
- The surgeon will inject up to 0.5 mL of reconstituted Tc-99m tilmanocept using a blunt tipped needle 1 cm into the wall of the resection cavity after completing surgical resection of the tumor
- SPECT/CT of the head and neck will be obtained when practical on the day of surgery.
If the patient is not sufficiently recovered from surgery to be transported to the Division of Nuclear Medicine for imaging, SPECT/CT will be done on Day 2
干预措施: Tc-99m tilmanocept (Drug)
Cohort 2B: Tc-99m tilmanocept parietal lobe injection site
- The surgeon will inject up to 0.5 mL of reconstituted Tc-99m tilmanocept using a blunt tipped needle 1 cm into the wall of the resection cavity after completing surgical resection of the tumor
- SPECT/CT of the head and neck will be obtained when practical on the day of surgery.
If the patient is not sufficiently recovered from surgery to be transported to the Division of Nuclear Medicine for imaging, SPECT/CT will be done on Day 2
干预措施: Tc-99m tilmanocept (Drug)
Cohort 2C: Tc-99m tilmanocept temporal lobe injection site
- The surgeon will inject up to 0.5 mL of reconstituted Tc-99m tilmanocept using a blunt tipped needle 1 cm into the wall of the resection cavity after completing surgical resection of the tumor
- SPECT/CT of the head and neck will be obtained when practical on the day of surgery.
If the patient is not sufficiently recovered from surgery to be transported to the Division of Nuclear Medicine for imaging, SPECT/CT will be done on Day 2
干预措施: Tc-99m tilmanocept (Drug)
Cohort 2D: Tc-99m tilmanocept occipital lobe injection site
- The surgeon will inject up to 0.5 mL of reconstituted Tc-99m tilmanocept using a blunt tipped needle 1 cm into the wall of the resection cavity after completing surgical resection of the tumor
- SPECT/CT of the head and neck will be obtained when practical on the day of surgery.
If the patient is not sufficiently recovered from surgery to be transported to the Division of Nuclear Medicine for imaging, SPECT/CT will be done on Day 2
干预措施: Tc-99m tilmanocept (Drug)
Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor
- The surgeon will inject up to 0.3 mL of reconstituted Tc-99m tilmanocept after completing the stereotactic biopsy of the tumor
- SPECT/CT of the head and neck will be obtained on the day of biopsy, when practical. If the patient is not sufficiently recovered from biopsy to be transported to the Division of Nuclear Medicine for imaging, SPECT/CT will be done on Day 2
干预措施: Tc-99m tilmanocept (Drug)
结局指标
主要结局
Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes
时间窗: Up to Day 2
Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only)
时间窗: Up to Day 2
次要结局
未报告次要终点