This study is being conducted to evaluate the use of a drug, aminolevulinic acid hydrochloride (ALA) that can light up (fluoresce) the borders between tumor and normal tissue in the brain. The use of this drug may help in removal of the tumor because the surgeon will be better able to tell the difference between tumor tissue and normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01116661.
PRIMARY OBJECTIVES:
I. To determine if the use of 5-aminolevulinic acid (ALA) helps distinguish tumor cells from normal cells leading to an increase in the amount of tumor removal during neurosurgical resection of glioma.
SECONDARY OBJECTIVES:
II. Determine the safety of a single dose of 5-aminolevulinic acid (ALA) administered preoperatively at a dose of 20 mg/kg body weight.
OUTLINE:
Patients receive ALA orally (PO) approximately 3 hours prior to anesthesia, and then undergo image-guided surgical resection.
After completion of study treatment, patients are followed up for 14 days.
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorMitchel S. Berger