Clinical trial · Interventional
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
NCT03752203CI-TRIAL-00086863terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study cancelled by PI.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Neurosurgical Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microscopic Resection | Device | — | UNRESOLVED |
| Sodium Fluorescein | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sodium-Fluorescein Resection
- description
- 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.
- interventionNames
- Drug: Sodium Fluorescein
- Device: Microscopic Resection
Primary outcomes (2)
- measure
- Percent of Tumor Resected: Intracranial Lesions
- timeFrame
- Pre-op assessment to outpatient follow up, up to 6 weeks
- description
- 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.
- measure
- Percent of Tumor Resected: Spinal Lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 31 Days
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.