Clinical trial NCT03752203: Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
Official title: Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Neurosurgical Tumors
Keywords: Sodium Fluorescein
Surgical Microscope
Central Nervous System
Tumors
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 2
Sex: ALL
Minimum age (years): 31
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Percent of Tumor Resected: Intracranial Lesions
timeFrame: Pre-op assessment to outpatient follow up, up to 6 weeks
measure: Percent of Tumor Resected: Spinal Lesions
timeFrame: Pre-op assessment to outpatient follow up, up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Todd Hankinson, MD
role: PRINCIPAL_INVESTIGATOR
References: