Glioma Clinical Trial
Official title:
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in
removing brain tumors during surgery. When ALA is provided at an increased concentration,
protoporphorin concentration in the malignant cell increases and renders the cell
fluorescent under long ultraviolet light. This study looks at using oral ALA to help
identify the tumor cells intraoperatively and facilitate complete resection.
Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following
tumor resection under light microscopy, the tumor bed will be illuminated and any residual
fluorescent tissue in cavity will be surgically removed leading to a more complete resection
of tumor. Pathologic confirmation of tumor type will be made by neuropathology.
Photosensitizer concentration in malignant and normal tissue will be estimated by
fluorescence microscopy.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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