Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
Status: | Not yet recruiting |
---|---|
Healthy: | No |
Age Range: | Any - 21 |
Updated: | 2/17/2019 |
Start Date: | July 2019 |
End Date: | June 2022 |
Contact: | Sarah Graber |
Email: | Sarah.Graber@childrenscolorado.org |
Phone: | 720-777-1862 |
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.
the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical
tumors.
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.
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.
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.
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Todd Hankinson, MD
Phone: 720-777-1862
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