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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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 2
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
1,945 Previous Clinical Trials
2,304,549 Total Patients Enrolled
Lloyd J. Old STAR ProgramUNKNOWN
Gavin P Dunn, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to dextran or similar substances.You had surgery to remove lymph nodes from your head or neck in the past.You are being considered for surgery to remove or take a sample of a suspected brain tumor, whether it's benign or malignant.You are able to receive a specific injection and imaging after surgery as determined by the study doctor or your treating neurosurgeon.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2A: Tc-99m tilmanocept frontal lobe injection site
- Group 2: Cohort 2B: Tc-99m tilmanocept parietal lobe injection site
- Group 3: Cohort 1: Tc-99m tilmanocept
- Group 4: Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor
- Group 5: Cohort 2C: Tc-99m tilmanocept temporal lobe injection site
- Group 6: Cohort 2D: Tc-99m tilmanocept occipital lobe injection site
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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