Central Nervous System Neoplasms, Central Nervous System Tumor
Conditions
Brief summary
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.
Interventions
Tc-99m tilmanocept is a radioactive diagnostic agent.
Sponsors
Lloyd J. Old STAR Program
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Documented hypersensitivity to dextran and/or modified forms of dextran. * Pregnant. * Prior surgical evacuation of lymph nodes of the head and/or neck
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only) | Up to Day 2 |
| Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes | Up to Day 2 |
Countries
United States
Outcome results
None listed