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Mapping Draining Lymph Nodes in CNS Malignancies

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ClinicalTrials.gov Identifier: NCT04096716
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
Lloyd J. Old STAR Program
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Central Nervous System Neoplasms Central Nervous System Tumor Drug: Tc-99m tilmanocept Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mapping Draining Lymph Nodes in CNS Malignancies
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Tc-99m tilmanocept
Tc-99m tilmanocept is a radioactive diagnostic agent.
Other Name: Lymphoseek

Experimental: 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

Drug: Tc-99m tilmanocept
Tc-99m tilmanocept is a radioactive diagnostic agent.
Other Name: Lymphoseek

Experimental: 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

Drug: Tc-99m tilmanocept
Tc-99m tilmanocept is a radioactive diagnostic agent.
Other Name: Lymphoseek

Experimental: 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

Drug: Tc-99m tilmanocept
Tc-99m tilmanocept is a radioactive diagnostic agent.
Other Name: Lymphoseek

Experimental: 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

Drug: Tc-99m tilmanocept
Tc-99m tilmanocept is a radioactive diagnostic agent.
Other Name: Lymphoseek




Primary Outcome Measures :
  1. Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only) [ Time Frame: Up to Day 2 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for surgical resection 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 injection and study related imaging post-op per the PI 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096716


Contacts
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Contact: Gavin P Dunn, M.D., Ph.D. 314-747-6141 gpdunn@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Gavin P Dunn, M.D., Ph.D.    314-747-6141    gpdunn@wustl.edu   
Principal Investigator: Gavin P Dunn, M.D., Ph.D.         
Sub-Investigator: Barry A Siegel, M.D.         
Sub-Investigator: Tanner M Johanns, M.D., Ph.D.         
Sub-Investigator: Andrew Coxon         
Sub-Investigator: Rupen Desai, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Lloyd J. Old STAR Program
Investigators
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Principal Investigator: Gavin P Dunn, M.D., Ph.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04096716    
Other Study ID Numbers: 201908018
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases