Mapping Draining Lymph Nodes in CNS Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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Mapping Draining Lymph Nodes in CNS Malignancies

Conditions
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Central Nervous System Neoplasms, Central Nervous System Tumor

Intervention / Treatment
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* Drug: Tc-99m tilmanocept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Tc-99m tilmanocept<br>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. | Drug: Tc-99m tilmanocept<br>* Tc-99m tilmanocept is a radioactive diagnostic agent.<br>* Other names: Lymphoseek;|
| Experimental: Cohort 2A: Tc-99m tilmanocept frontal lobe injection site<br>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 | Drug: Tc-99m tilmanocept<br>* Tc-99m tilmanocept is a radioactive diagnostic agent.<br>* Other names: Lymphoseek;|
| Experimental: Cohort 2B: Tc-99m tilmanocept parietal lobe injection site<br>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 | Drug: Tc-99m tilmanocept<br>* Tc-99m tilmanocept is a radioactive diagnostic agent.<br>* Other names: Lymphoseek;|
| Experimental: Cohort 2C: Tc-99m tilmanocept temporal lobe injection site<br>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 | Drug: Tc-99m tilmanocept<br>* Tc-99m tilmanocept is a radioactive diagnostic agent.<br>* Other names: Lymphoseek;|
| Experimental: Cohort 2D: Tc-99m tilmanocept occipital lobe injection site<br>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 | Drug: Tc-99m tilmanocept<br>* Tc-99m tilmanocept is a radioactive diagnostic agent.<br>* Other names: Lymphoseek;|
| Experimental: Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor<br>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 | Drug: Tc-99m tilmanocept<br>* Tc-99m tilmanocept is a radioactive diagnostic agent.<br>* Other names: Lymphoseek;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |