Pediatric Neurosurgical Tumors
Conditions
Keywords
Sodium Fluorescein, Surgical Microscope, Central Nervous System, Tumors
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.
Interventions
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
DEVICEMicroscopic 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.
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.
Eligibility
Sex/Gender
ALL
Age
31 Days to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Tumor Resected: Intracranial Lesions | Pre-op assessment to outpatient follow up, up to 6 weeks | 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. |
| Percent of Tumor Resected: Spinal Lesions | Pre-op assessment to outpatient follow up, up to 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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
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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Sodium-Fluorescein Resection |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6 years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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.
Time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
Population: Data not collected or analyzed and therefore cannot be reported . Study was terminated due to lack of patients and funding. The Outcome Measure Data Table is not able to be completed due to lack of data.
Primary
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.
Time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
Population: Data not collected.
Post Hoc
No Outcome Measures Were Completed Due to Data Not Collected Due to Lack of Patients and Funding.
No Outcome Measures were completed due to data not collected due to lack of patients and funding.
Time frame: No Outcome Measures were completed due to data not collected due to lack of patients and funding.