Adult Intracranial Neoplasm, Vascular: Intracranial
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.
Detailed description
The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions. The objectives of this study aim to investigate the use of Fluorescein in assisting with evaluating complete tumor removal and thorough treatment of intracranial vascular lesions as well as tumor biopsy procedures. The hypothesis is that Fluorescein Sodium will help surgeons better identify residual tumor and vascular lesions and its use will allow surgeons to obtain better surgical results and prognostic outcomes.
Interventions
All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
Sponsors
Sentara Norfolk General Hospital
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Diagnosed by preoperative imaging modalities to have a brain tumor or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention. * The patient is determined by a board certified Neurosurgeon (above mentioned neurosurgeons) to benefit from the application of Fluorescein Sodium intraoperatively * Patient or legally authorized representative provides written informed consent to enroll in this study.
Exclusion criteria
* Known allergic reaction to Fluorescein Sodium. * Children. * Prisoners. * Students. * Infection of the central nervous system or other sites. * Hemodynamic instability or significant impairments in circulation. * Concomitant treatment with other investigational drugs. * Any uncontrolled condition unrelated to the neurosurgical disease. * History of psychiatric, additive, or any other disorder that compromises the ability to provide informed consent or comply with study protocols. * Participation on other clinical trials during the last thirty days. * Pregnant patients. * Patients unable to discontinue medications that affect Fluorescein metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging | up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation. | We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion. |
Countries
United States
Participant flow
Pre-assignment details
10 participants failed screening
Participants by arm
| Arm | Count |
|---|---|
| Fluorescein Sodium All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography. | 136 |
| Total | 136 |
Baseline characteristics
| Characteristic | Fluorescein Sodium |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 32 Participants |
| Age, Categorical Between 18 and 65 years | 104 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 126 |
| serious Total, serious adverse events | 0 / 126 |
Outcome results
Primary
Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging
We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.
Time frame: up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluorescein Sodium | Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging | Concordance | 84 participants |
| Fluorescein Sodium | Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging | Nonconcordance | 10 participants |
| Fluorescein Sodium | Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging | Unable to reliably assess | 32 participants |