Mapping Draining Lymph Nodes in CNS Malignancies

Central Nervous System Tumor Clinical Trial

Official title:

Mapping Draining Lymph Nodes in CNS Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04096716
• Other study ID #: 201908018
• Status: Terminated
• Phase: Phase 1
• Start date: December 3, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Nervous System Neoplasms

Intervention

Drug:
• Tc-99m tilmanocept
Tc-99m tilmanocept is a radioactive diagnostic agent.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Lloyd J. Old STAR Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only)		Up to Day 2
Primary	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

External Links

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