Central Nervous System NeoplasmsPhase 1NCT04096716
Mapping Draining Lymph Nodes in CNS Malignancies
A Phase 1 study testing Tc-99m tilmanocept in people with Central Nervous System Neoplasms and Central Nervous System Tumor, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Neoplasms, Central Nervous System Tumor
- What is being tested?
- Tc-99m tilmanocept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 30 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Documented hypersensitivity to dextran and/or modified forms of dextran.
- Pregnant.
- Prior surgical evacuation of lymph nodes of the head and/or neck
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Being tested
- Tc-99m tilmanocept
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc-99m tilmanoceptDrug
Also called Lymphoseek
Tc-99m tilmanocept is a radioactive diagnostic agent.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Tc-99m tilmanocept | Experimental | * 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. Receives: Drug: Tc-99m tilmanocept |
| Cohort 2A: Tc-99m tilmanocept frontal lobe injection site | Experimental | * 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 Receives: Drug: Tc-99m tilmanocept |
| Cohort 2B: Tc-99m tilmanocept parietal lobe injection site | Experimental | * 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 Receives: Drug: Tc-99m tilmanocept |
| Cohort 2C: Tc-99m tilmanocept temporal lobe injection site | Experimental | * 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 Receives: Drug: Tc-99m tilmanocept |
| Cohort 2D: Tc-99m tilmanocept occipital lobe injection site | Experimental | * 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 Receives: Drug: Tc-99m tilmanocept |
| Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor | Experimental | * 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 Receives: Drug: Tc-99m tilmanocept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only)
Measured: Up to Day 2
Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes
Measured: Up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start3 Dec 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Why it stopped: Insufficient funding/staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Lloyd J. Old STAR Program
- Responsible party
- Sponsor
- Investigators
- Tanner Johanns, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096716
- Sponsor's protocol ID
- 201908018
- Status last verified
- Dec 2023
- First submitted
- 18 Sep 2019
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Draining Lymph Nodes in CNS Malignancies
- ClinicalTrials.gov ID
- NCT04096716
- Acronym / sponsor ID
- 201908018
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding/staff
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Lloyd J. Old STAR Program
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Tc-99m tilmanocept | Experimental | Drug: 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. |
| Cohort 2A: Tc-99m tilmanocept frontal lobe injection site | Experimental | Drug: 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 |
| Cohort 2B: Tc-99m tilmanocept parietal lobe injection site | Experimental | Drug: 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 |
| Cohort 2C: Tc-99m tilmanocept temporal lobe injection site | Experimental | Drug: 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 |
| Cohort 2D: Tc-99m tilmanocept occipital lobe injection site | Experimental | Drug: 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 |
| Cohort 3: Tc-99m tilmanocept stereotactic needle biopsy of tumor | Experimental | Drug: Tc-99m tilmanocept* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Documented hypersensitivity to dextran and/or modified forms of dextran.
- Pregnant.
- Prior surgical evacuation of lymph nodes of the head and/or neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc-99m tilmanoceptAlso: LymphoseekTc-99m tilmanocept is a radioactive diagnostic agent. | Drug | 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 |
Primary outcome
Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only)
Time frame: Up to Day 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
Results and safety
The study was stopped early (reason given: Insufficient funding/staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanner Johanns, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tc-99m tilmanocept in people with Central Nervous System Neoplasms and Central Nervous System Tumor, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient funding/staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only) (time frame: Up to Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.