Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Study Overview
=================
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.

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.

Official Title
-----------------
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Conditions
-----------------
Pediatric Neurosurgical Tumors

Intervention / Treatment
-----------------
* Drug: Sodium Fluorescein
* Device: Microscopic Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 31 Days
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium-Fluorescein Resection<br>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<br>* 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<br>Device: Microscopic Resection<br>* Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumors, Sodium Fluorescein, Surgical Microscope, Central Nervous System