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
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
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- 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