Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Pediatric Neurosurgical Tumors
• Intervention / Treatment: Drug: Sodium Fluorescein; Device: Microscopic Resection

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sodium-Fluorescein Resection; 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.

Drug: Sodium Fluorescein; 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; Device: Microscopic Resection; Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Pre-op assessment to outpatient follow up, up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Utility	The doctor's satisfaction with the resection of the tumor(s) will be based upon pre and post imaging, as well as his or her personal experience.	Pre-op assessment to outpatient follow up, up to 6 weeks
Positive Predictive Value	PPV will be calculated using contingency tables and the data from the tumor extraction.	Pre-op assessment to outpatient follow up, up to 6 weeks
Sensitivity of Tumor Resection	Tissue obtained during the time of surgery will be used to correlate fluorescein staining to histopathological diagnosis to determine sensitivity of fluorescein staining for tumors.	Pre-op assessment to outpatient follow up, up to 6 weeks
Specificity of Tumor Resection	Tissue obtained during the time of surgery will be used to correlate fluorescein staining to histopathological diagnosis to determine specificity of fluorescein staining for tumors.	Pre-op assessment to outpatient follow up, up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Todd Hankinson, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Central Nervous System; Tumors; Sodium Fluorescein; Surgical Microscope
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 18-0242.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes