Vik Udani, MD
Medical Director of Neurosurgery, Laurel Amtower Cancer Institute
Laurel Amtower Neuro-Oncology Center, Sharp Healthcare
The primary objective of this feasibility study is to evaluate sensitivity and specificity of the combination use of Fluorescein dye (fluorescent marker sodium fluorescein) and the YELLOW 560 fluorescence module available for ZEISS PENTERO 900 (YE 560) for intra-operative visualization of low grade glioma (LGG) and metastatic tumors. Biopsy or resection specimens sent to pathology shall act as the control and provide the diagnostic “gold standard”.
Current practice during tumor resection is to take biopsies to analyze the tissue for verifying the tissue being tumor or not. Studies on the use of intra operative fluorescence for resection indicate its positive effect on the likelihood to increase the Gross Total Resection (GTR) rate.
A total of 20 consenting patients, either male or female, clinically indicated for neurosurgical resection as a newly diagnosed suspected low grade glioma (10 patients) or metastatic tumor (10 patients) will be eligible for enrollment into the study.
Primary outcomes of this study are the sensitivity and specificity of the combinatory use of fluorescein and YE 560 for intra-operative visualization of low grade glioma or metastatic tumor, determined from histopathology of co-registered biopsy samples obtained intra‐operatively as the gold standard.
Potential benefits to subjects who participate in this study are maximizing the extent of tumor resection while minimizing the risk of neurological deficits. Through development of a new technology that could help neurosurgeons improve treatment for patients with brain tumors, there are possible benefits to society.