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NCT04096716

Mapping Draining Lymph Nodes in CNS Malignancies

NCT ID: NCT04096716

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2022-04-30

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.

Detailed Description

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Conditions

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Central Nervous System Neoplasms Central Nervous System Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tc-99m tilmanocept

Intervention Type DRUG

Tc-99m tilmanocept is a radioactive diagnostic agent.

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

Group Type EXPERIMENTAL

Tc-99m tilmanocept

Intervention Type DRUG

Tc-99m tilmanocept is a radioactive diagnostic agent.

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

Group Type EXPERIMENTAL

Tc-99m tilmanocept

Intervention Type DRUG

Tc-99m tilmanocept is a radioactive diagnostic agent.

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

Group Type EXPERIMENTAL

Tc-99m tilmanocept

Intervention Type DRUG

Tc-99m tilmanocept is a radioactive diagnostic agent.

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

Group Type EXPERIMENTAL

Tc-99m tilmanocept

Intervention Type DRUG

Tc-99m tilmanocept is a radioactive diagnostic agent.

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

Group Type EXPERIMENTAL

Tc-99m tilmanocept

Intervention Type DRUG

Tc-99m tilmanocept is a radioactive diagnostic agent.

Interventions

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Tc-99m tilmanocept

Tc-99m tilmanocept is a radioactive diagnostic agent.

Intervention Type DRUG

Other Intervention Names

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Lymphoseek

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lloyd J. Old STAR Program

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanner Johanns, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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201908018

Identifier Type: -

Identifier Source: org_study_id