Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Pediatric Neurosurgical Tumors

Treatments: Device: Microscopic Resection; Drug: Sodium Fluorescein

Study type: Interventional

Funder types: Other

Identifiers

NCT03752203

18-0242.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 31 days to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Sodium-Fluorescein Resection

Experimental group

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.

Treatment:

Drug: Sodium Fluorescein

Device: Microscopic Resection