Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Pediatric Neurosurgical Tumors Clinical Trial

Official title:

Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03752203
• Other study ID #: 18-0242.cc
• Status: Terminated
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Days to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Pediatric Neurosurgical Tumors

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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