Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2023-06-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Neurosurgical Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.

Study Groups

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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.

Group Type EXPERIMENTAL

Sodium Fluorescein

Intervention Type 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

Microscopic Resection

Intervention Type 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.

Interventions

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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

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

31 Days

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No