Status:
TERMINATED
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
Lead Sponsor:
University of Colorado, Denver
Conditions:
Pediatric Neurosurgical Tumors
Eligibility:
All Genders
31-21 years
Phase:
NA
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03752203
Start Date
August 11 2021
End Date
June 29 2023
Last Update
March 6 2025
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045