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Lymph Node Mapping with Tc-99m Tilmanocept for Brain Cancer

Phase 1
Waitlist Available
Led By Gavin P Dunn, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 2
Awards & highlights

Study Summary

This trial is testing whether a brain tumor's lymph nodes can be found by injecting a radioactive substance & scanning the body.

Who is the study for?
This trial is for adults who are candidates for brain tumor surgery or biopsy, including those with benign (e.g., meningioma) or malignant tumors (e.g., glioma). They must be able to receive an injection of Tc-99m tilmanocept and undergo post-operative imaging. People can't join if they're allergic to dextran, pregnant, or have had lymph node surgery in the head/neck area.Check my eligibility
What is being tested?
The study tests whether injecting a radioactive substance called Tc-99m tilmanocept into brain tissue around a tumor helps map the draining lymph nodes by tracking its movement using special imaging techniques. The goal is to see how quickly it travels from the tumor to the lymph nodes.See study design
What are the potential side effects?
Potential side effects may include reactions related to hypersensitivity to dextran since Tc-99m tilmanocept contains this substance. However, specific side effects are not detailed here and would depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are being considered for surgery to remove or take a sample of a suspected brain tumor, whether it's benign or malignant.
Select...
You are able to receive a specific injection and imaging after surgery as determined by the study doctor or your treating neurosurgeon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes
Brain

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumorExperimental Treatment1 Intervention
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 II: Cohort 2D: Tc-99m tilmanocept occipital lobe injection siteExperimental Treatment1 Intervention
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 III: Cohort 2C: Tc-99m tilmanocept temporal lobe injection siteExperimental Treatment1 Intervention
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 IV: Cohort 2B: Tc-99m tilmanocept parietal lobe injection siteExperimental Treatment1 Intervention
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 V: Cohort 2A: Tc-99m tilmanocept frontal lobe injection siteExperimental Treatment1 Intervention
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 VI: Cohort 1: Tc-99m tilmanoceptExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,074 Total Patients Enrolled
Lloyd J. Old STAR ProgramUNKNOWN
Gavin P Dunn, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

Media Library

Tc-99m tilmanocept Clinical Trial Eligibility Overview. Trial Name: NCT04096716 — Phase 1
Brain Tumor Research Study Groups: Cohort 2C: Tc-99m tilmanocept temporal lobe injection site, Cohort 2B: Tc-99m tilmanocept parietal lobe injection site, Cohort 2D: Tc-99m tilmanocept occipital lobe injection site, Cohort 1: Tc-99m tilmanocept, Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor, Cohort 2A: Tc-99m tilmanocept frontal lobe injection site
Brain Tumor Clinical Trial 2023: Tc-99m tilmanocept Highlights & Side Effects. Trial Name: NCT04096716 — Phase 1
Tc-99m tilmanocept 2023 Treatment Timeline for Medical Study. Trial Name: NCT04096716 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for participants to join this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour is currently looking for qualified patients; it was initially published on December 3rd 2019 and edited most recently on January 28th 2022. The study necessitates 30 participants at a single medical facility."

Answered by AI

What diseases are most commonly treated using Tc-99m tilmanocept?

"Tc-99m tilmanocept is most commonly deployed in the treatment of malignant melanoma. However, it has also proven useful for breast cancer diagnosis, oral carcinomas, and other medical imaging purposes."

Answered by AI

What potential risks should individuals be aware of before taking Tc-99m tilmanocept?

"Considering the preliminary nature of this Phase 1 trial, our team at Power assigned Tc-99m tilmanocept a safety rating of 1 due to limited data regarding its efficacy and safety."

Answered by AI

Could you elaborate on the other experiments that have been conducted involving Tc-99m tilmanocept?

"At present, 2 studies are underway researching the efficacy of Tc-99m tilmanocept with none having reached Phase 3. Available trials span 7 locations across London and California."

Answered by AI

How many participants are being monitored in this clinical trial?

"Affirmative. Recent updates on clinicaltrials.gov demonstrate that this trial commenced its recruitment phase on December 3rd 2019 and is still actively searching for 30 participants at one location."

Answered by AI
~3 spots leftby Mar 2025