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NCT04096716 Clinical Trial

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
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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