Pediatric Neurosurgical TumorsNCT03752203
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
A study testing Sodium Fluorescein and Microscopic Resection in people with Pediatric Neurosurgical Tumors, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors. Read more about this study
- Who is it for?
- Ages 31 days to 21 years
- Conditions the study is for
- Pediatric Neurosurgical Tumors
- What is being tested?
- Sodium Fluorescein and Microscopic Resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2021to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 31 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 31 days through 21 years on date of surgery
- Undergoing resection of a central nervous system tumor at Children's Hospital Colorado
- Parent/legal guardian (or adult subject) willing and able to complete the informed consent process
Who cannot join
- Tumor in functionally eloquent cortex that precludes maximal surgical resection
- Severe renal dysfunction
- Preoperative serum creatinine level > than normal range and GFR < 30.
- Severe liver dysfunction
- History of asthma or pulmonary spasm
- Known allergy to sodium fluorescein or any other contrast dye
Show all 9Show fewer
- Previous administration of sodium fluorescein within the last 72 hours
- Pregnant or nursing mother
- Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors.
Read the detailed description
This study will be a prospective non-randomized cohort study with patients presenting to Children's Hospital Colorado for resection of a central nervous system tumor. This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. Fluorescein sodium is a small organic salt that accumulates in areas of diminished blood-brain barrier integrity and allows for determination of the margins between tumor and normal brain function.
- Conditions
- Pediatric Neurosurgical Tumors
- Being tested
- Sodium Fluorescein, Microscopic Resection
- Keywords
- Sodium Fluorescein, Surgical Microscope, Central Nervous System, Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium FluoresceinDrug
Patients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds
Microscopic ResectionDevice
Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.
| Study group | Role | What they receive |
|---|---|---|
| Sodium-Fluorescein Resection | Experimental | This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. Receives: Drug: Sodium Fluorescein; Device: Microscopic Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Tumor Resected: Intracranial Lesions
For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In intracranial lesions, the use of volumetric imaging tools will be used to calculate the extent of tumor resection.
Measured: Pre-op assessment to outpatient follow up, up to 6 weeks
Percent of Tumor Resected: Spinal Lesions
For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In spinal lesions, manual measurement will be used to determine the extent of resection.
Measured: Pre-op assessment to outpatient follow up, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start11 Aug 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Why it stopped: Study cancelled by PI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Neurosurgical TumorsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The primary neurosurgeons who will perform the resections will be investigators on the study and will identify eligible patients from the established practice. At the time surgical intervention is recommended, the doctors will inform patients and parents/guardians of the existence of the study. Only those subjects with a clinical relationship to the study investigators will be recruited.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Hankinson, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752203
- Sponsor's protocol ID
- 18-0242.cc
- Status last verified
- Mar 2025
- First submitted
- 21 Nov 2018
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
- ClinicalTrials.gov ID
- NCT03752203
- Acronym / sponsor ID
- 18-0242.cc
- Conditions
- Pediatric Neurosurgical Tumors
- Keywords
- Sodium Fluorescein, Surgical Microscope, Central Nervous System, Tumors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study cancelled by PI.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors.
Detailed description
This study will be a prospective non-randomized cohort study with patients presenting to Children's Hospital Colorado for resection of a central nervous system tumor. This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. Fluorescein sodium is a small organic salt that accumulates in areas of diminished blood-brain barrier integrity and allows for determination of the margins between tumor and normal brain function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The primary neurosurgeons who will perform the resections will be investigators on the study and will identify eligible patients from the established practice. At the time surgical intervention is recommended, the doctors will inform patients and parents/guardians of the existence of the study. Only those subjects with a clinical relationship to the study investigators will be recruited.
| Arm | Type | Receives |
|---|---|---|
| Sodium-Fluorescein Resection | Experimental | Drug: Sodium Fluorescein, Device: Microscopic ResectionThis study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. |
Who may qualify
- Ages
- 31 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 31 days through 21 years on date of surgery
- Undergoing resection of a central nervous system tumor at Children's Hospital Colorado
- Parent/legal guardian (or adult subject) willing and able to complete the informed consent process
Key exclusion criteria (9 listed)
- Tumor in functionally eloquent cortex that precludes maximal surgical resection
- Severe renal dysfunction
- Preoperative serum creatinine level > than normal range and GFR < 30.
- Severe liver dysfunction
- History of asthma or pulmonary spasm
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 |
|---|---|---|
| Sodium FluoresceinPatients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds | Drug | Sodium-Fluorescein Resection |
| Microscopic ResectionResection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. | Device | Sodium-Fluorescein Resection |
Primary outcome
Percent of Tumor Resected: Intracranial Lesions
Time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In intracranial lesions, the use of volumetric imaging tools will be used to calculate the extent of tumor resection.
Percent of Tumor Resected: Spinal Lesions
Time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In spinal lesions, manual measurement will be used to determine the extent of resection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pediatric Neurosurgical Tumors
RecruitingPhase 1/2
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
Brain Tumor
RecruitingObservational study
Cerebellar Mutism Syndrome Study
Infratentorial Neoplasms, Mutism
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.
Todd Hankinson, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fluorescein and Microscopic Resection in people with Pediatric Neurosurgical Tumors, run by University of Colorado, Denver 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 3 inclusion and 9 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 6 Mar 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Tumor Resected: Intracranial Lesions (time frame: Pre-op assessment to outpatient follow up, up to 6 weeks). 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 6 Mar 2025.