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Mapping Draining Lymph Nodes in CNS Malignancies

Primary Purpose

Central Nervous System Neoplasms, Central Nervous System Tumor

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tc-99m tilmanocept
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central Nervous System Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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.

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

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

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

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

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

Outcomes

Primary Outcome Measures

Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only)
Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes

Secondary Outcome Measures

Full Information

First Posted
September 18, 2019
Last Updated
December 19, 2022
Sponsor
Washington University School of Medicine
Collaborators
Lloyd J. Old STAR Program
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1. Study Identification

Unique Protocol Identification Number
NCT04096716
Brief Title
Mapping Draining Lymph Nodes in CNS Malignancies
Official Title
Mapping Draining Lymph Nodes in CNS Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Lloyd J. Old STAR Program

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Neoplasms, Central Nervous System Tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Tc-99m tilmanocept
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2A: Tc-99m tilmanocept frontal lobe injection site
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2B: Tc-99m tilmanocept parietal lobe injection site
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2C: Tc-99m tilmanocept temporal lobe injection site
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2D: Tc-99m tilmanocept occipital lobe injection site
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tc-99m tilmanocept
Other Intervention Name(s)
Lymphoseek
Intervention Description
Tc-99m tilmanocept is a radioactive diagnostic agent.
Primary Outcome Measure Information:
Title
Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only)
Time Frame
Up to Day 2
Title
Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes
Time Frame
Up to Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanner Johanns, M.D., Ph.D.
Phone
314-273-2723
Email
tannerjohanns@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanner Johanns, M.D., Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanner Johanns, M.D., Ph.D.
Phone
314-273-2723
Email
tannerjohanns@wustl.edu
First Name & Middle Initial & Last Name & Degree
Tanner Johanns, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Barry A Siegel, M.D.
First Name & Middle Initial & Last Name & Degree
Andrew Coxon
First Name & Middle Initial & Last Name & Degree
Rupen Desai, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Mapping Draining Lymph Nodes in CNS Malignancies

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