Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT03752203
Status:
TERMINATED
Last Update Posted:
2025-03-06
First Post:
2018-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019793', 'term': 'Fluorescein'}], 'ancestors': [{'id': 'D005452', 'term': 'Fluoresceins'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014966', 'term': 'Xanthenes'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'todd.hankinson@childrenscolorado.org', 'phone': '7207776100', 'title': 'Dr. Todd Hankinson', 'organization': "Children's Hospital Colorado"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was discontinued due to lack of funding and patients.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sodium-Fluorescein Resection', 'description': '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.\n\nSodium 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\n\nMicroscopic 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.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Tumor Resected: Intracranial Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium-Fluorescein Resection', 'description': '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.\n\nSodium 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\n\nMicroscopic 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.'}], 'timeFrame': 'Pre-op assessment to outpatient follow up, up to 6 weeks', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Percent of Tumor Resected: Spinal Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium-Fluorescein Resection', 'description': '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.\n\nSodium 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\n\nMicroscopic 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.'}], 'timeFrame': 'Pre-op assessment to outpatient follow up, up to 6 weeks', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'POST_HOC', 'title': 'No Outcome Measures Were Completed Due to Data Not Collected Due to Lack of Patients and Funding.', 'timeFrame': 'No Outcome Measures were completed due to data not collected due to lack of patients and funding.', 'description': 'No Outcome Measures were completed due to data not collected due to lack of patients and funding.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium-Fluorescein Resection', 'description': '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.\n\nSodium 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\n\nMicroscopic 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium-Fluorescein Resection', 'description': '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.\n\nSodium 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\n\nMicroscopic 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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-28', 'size': 479694, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-11-10T09:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized."}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study cancelled by PI.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2018-11-21', 'resultsFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2018-11-21', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-12', 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Tumor Resected: Intracranial Lesions', 'timeFrame': 'Pre-op assessment to outpatient follow up, up to 6 weeks', 'description': '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.'}, {'measure': 'Percent of Tumor Resected: Spinal Lesions', 'timeFrame': 'Pre-op assessment to outpatient follow up, up to 6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Sodium Fluorescein', 'Surgical Microscope', 'Central Nervous System', 'Tumors'], 'conditions': ['Pediatric Neurosurgical Tumors']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '31 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 31 days through 21 years on date of surgery\n* Undergoing resection of a central nervous system tumor at Children's Hospital Colorado\n* Parent/legal guardian (or adult subject) willing and able to complete the informed consent process\n\nExclusion Criteria:\n\n* Tumor in functionally eloquent cortex that precludes maximal surgical resection\n* Severe renal dysfunction\n* Preoperative serum creatinine level \\> than normal range and GFR \\< 30.\n* Severe liver dysfunction\n* History of asthma or pulmonary spasm\n* Known allergy to sodium fluorescein or any other contrast dye\n* Previous administration of sodium fluorescein within the last 72 hours\n* Pregnant or nursing mother\n* Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment."}, 'identificationModule': {'nctId': 'NCT03752203', 'briefTitle': 'Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors', 'orgStudyIdInfo': {'id': '18-0242.cc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium-Fluorescein Resection', 'description': '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.', 'interventionNames': ['Drug: Sodium Fluorescein', 'Device: Microscopic Resection']}], 'interventions': [{'name': 'Sodium Fluorescein', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Sodium-Fluorescein Resection']}, {'name': 'Microscopic Resection', 'type': 'DEVICE', 'description': 'Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.', 'armGroupLabels': ['Sodium-Fluorescein Resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Todd Hankinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}