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Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

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ClinicalTrials.gov Identifier: NCT03752203
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Neurosurgical Tumors Drug: Sodium Fluorescein Device: Microscopic Resection Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description: Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.
Primary Purpose: Other
Official Title: Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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

Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Tumor Resected: Intracranial Lesions [ Time Frame: 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.

  2. Percent of Tumor Resected: Spinal Lesions [ Time Frame: 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.


Secondary Outcome Measures :
  1. Subjective Utility [ Time Frame: Pre-op assessment to outpatient follow up, up to 6 weeks ]
    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.

  2. Positive Predictive Value [ Time Frame: Pre-op assessment to outpatient follow up, up to 6 weeks ]
    PPV will be calculated using contingency tables and the data from the tumor extraction.

  3. Sensitivity of Tumor Resection [ Time Frame: Pre-op assessment to outpatient follow up, up to 6 weeks ]
    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.

  4. Specificity of Tumor Resection [ Time Frame: Pre-op assessment to outpatient follow up, up to 6 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   31 Days to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752203


Contacts
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Contact: Sarah Graber 720-777-1862 Sarah.Graber@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah Graber    720-777-1862    sarah.graber@childrenscolorado.org   
Principal Investigator: Todd Hankinson, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Todd Hankinson, MD Children's Hospital Colorado
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03752203    
Other Study ID Numbers: 18-0242.cc
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Colorado, Denver:
Sodium Fluorescein
Surgical Microscope
Central Nervous System
Tumors
Additional relevant MeSH terms:
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Neoplasms