Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

NCT03752203 | Terminated Results DMC FDA Device

• 1 other identifier: 18-0242.cc
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Neurosurgical Tumors

Keywords

Sodium Fluorescein; Surgical Microscope; Central Nervous System; Tumors

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Drug: Sodium Fluorescein; Device: Microscopic Resection

Interventions

Sodium Fluorescein DRUG

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

Sodium-Fluorescein Resection

Microscopic Resection DEVICE

Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.

Sodium-Fluorescein Resection

Eligibility Criteria

• Age: 31 Days - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorescein

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Study was discontinued due to lack of funding and patients.

Results Point of Contact

• Title: Dr. Todd Hankinson
• Organization: Children's Hospital Colorado

todd.hankinson@childrenscolorado.org

7207776100

Study Officials

• Todd Hankinson, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 23, 2018
• Study Start: August 11, 2021
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: March 6, 2025
• Results First Posted: February 14, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)