Mapping Draining Lymph Nodes in CNS Malignancies

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.

Study Overview

• Status: Terminated
• Conditions: Central Nervous System Neoplasms; Central Nervous System Tumor
• Intervention / Treatment: Drug: Tc-99m tilmanocept

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tanner Johanns, M.D., Ph.D.; Phone Number: 314-273-2723; Email: tannerjohanns@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tc-99m tilmanocept; Tc-99m tilmanocept is a radioactive diagnostic agent.; Other Names: Lymphoseek
Experimental: 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	Drug: Tc-99m tilmanocept; Tc-99m tilmanocept is a radioactive diagnostic agent.; Other Names: Lymphoseek
Experimental: 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	Drug: Tc-99m tilmanocept; Tc-99m tilmanocept is a radioactive diagnostic agent.; Other Names: Lymphoseek
Experimental: 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	Drug: Tc-99m tilmanocept; Tc-99m tilmanocept is a radioactive diagnostic agent.; Other Names: Lymphoseek
Experimental: 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	Drug: Tc-99m tilmanocept; Tc-99m tilmanocept is a radioactive diagnostic agent.; Other Names: Lymphoseek
Experimental: 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	Drug: Tc-99m tilmanocept; Tc-99m tilmanocept is a radioactive diagnostic agent.; Other Names: Lymphoseek

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Lloyd J. Old STAR Program
• Investigators: Principal Investigator: Tanner Johanns, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: 201908018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No