Mapping Draining Lymph Nodes in CNS Malignancies

NCT04096716 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 201908018
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Neoplasms; Central Nervous System Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

Cohort 1: Tc-99m tilmanocept

EXPERIMENTAL

* 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

Cohort 2A: Tc-99m tilmanocept frontal lobe injection site

EXPERIMENTAL

* 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

Cohort 2B: Tc-99m tilmanocept parietal lobe injection site

EXPERIMENTAL

* 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

Cohort 2C: Tc-99m tilmanocept temporal lobe injection site

EXPERIMENTAL

* 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

Cohort 2D: Tc-99m tilmanocept occipital lobe injection site

EXPERIMENTAL

* 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

Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor

EXPERIMENTAL

* 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

Interventions

Tc-99m tilmanocept DRUG

Tc-99m tilmanocept is a radioactive diagnostic agent.

Also known as: Lymphoseek

Cohort 1: Tc-99m tilmanocept; Cohort 2A: Tc-99m tilmanocept frontal lobe injection site; Cohort 2B: Tc-99m tilmanocept parietal lobe injection site; Cohort 2C: Tc-99m tilmanocept temporal lobe injection site; Cohort 2D: Tc-99m tilmanocept occipital lobe injection site; Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Documented hypersensitivity to dextran and/or modified forms of dextran.
• Pregnant.
• Prior surgical evacuation of lymph nodes of the head and/or neck

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Lloyd J. Old STAR Program: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Tanner Johanns, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: December 3, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)