Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/15/2017 |
| Start Date: | May 2015 |
| End Date: | April 2019 |
| Contact: | Cherlynn Basignani, BSN,RN,CCRC |
| Email: | cherlynn.basignani@flhosp.org |
| Phone: | 407-303-3247 |
This study focuses on implementing Yellow 560 for the direct intraoperative visualization of
Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop
better treatment protocols, and improve the prognosis of a wide array of neurosurgical
diseases. More specifically, for the patients who are undergoing surgical intervention for
the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the
investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or
in general residual lesion which must be corrected.
Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop
better treatment protocols, and improve the prognosis of a wide array of neurosurgical
diseases. More specifically, for the patients who are undergoing surgical intervention for
the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the
investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or
in general residual lesion which must be corrected.
The research design is a prospective clinical study. 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 500mg (100mg/ml) will be
administered intravenously (the optimal dosage will be determined within the study as the
most minimal dose for adequate visualization will be used). Surgery will continue with the
aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to
reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.
Conventional microsurgical and biopsy procedures and techniques including histopathology and
intraoperative imaging will be performed through the completion of the surgery. The surgeon
will resect and remove what he believes is the tumor based on previously known criteria
(standards of care) regardless of what the Fluorescein angiography demonstrates. 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.
No other additional neurosurgical instruments will be used. Patients will be treated
post-operatively with conventional adjunctive therapies and imaging as deemed necessary by
the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data
(including post-operative images assessing outcomes and complications) will be collected on
all patients on standard post-operative visits. Intra-operative films or recordings and all
patient data may be saved and used according to HIPAA allowances.
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 500mg (100mg/ml) will be
administered intravenously (the optimal dosage will be determined within the study as the
most minimal dose for adequate visualization will be used). Surgery will continue with the
aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to
reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.
Conventional microsurgical and biopsy procedures and techniques including histopathology and
intraoperative imaging will be performed through the completion of the surgery. The surgeon
will resect and remove what he believes is the tumor based on previously known criteria
(standards of care) regardless of what the Fluorescein angiography demonstrates. 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.
No other additional neurosurgical instruments will be used. Patients will be treated
post-operatively with conventional adjunctive therapies and imaging as deemed necessary by
the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data
(including post-operative images assessing outcomes and complications) will be collected on
all patients on standard post-operative visits. Intra-operative films or recordings and all
patient data may be saved and used according to HIPAA allowances.
Inclusion Criteria:
- Adult patients (age ≥ 18)
- Diagnosed by preoperative imaging modalities to have a brain tumor (including
metastatic brain tumors) or vascular lesions (aneurysm, arteriovenous malformation or
arteriovenous fistula) requiring surgical intervention.
- The patient is determined by a board certified neurosurgeon to have a tumor or
vascular lesion that would take up fluorescein
- Patient or legally authorized representative provides written informed consent to
enroll in this study
We found this trial at
1
site
Florida Hospital Florida Hospital is one of the country
Click here to add this to my saved trials
