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Study cancelled by PI.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium-Fluorescein Resection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Fluorescein | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Hankinson, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Pre-op assessment to outpatient follow up, up to 6 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Study was discontinued due to lack of funding and patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd Hankinson | Children's Hospital Colorado | 7207776100 | todd.hankinson@childrenscolorado.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 28, 2021 | Nov 10, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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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.
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Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.
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| Microscopic Resection | 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. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Data not collected. | Posted | Pre-op assessment to outpatient follow up, up to 6 weeks |
|
|
| 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. | Not Posted | No Outcome Measures were completed due to data not collected due to lack of patients and funding. | Participants |
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |