A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a
dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with
the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to
determine whether the tumor has been completely or partially resected. All subjects will be
followed for safety. All subjects will be followed closely by clinical examination and by
MRI to monitor for disease recurrence.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to disease progression after initial surgery.
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
Up to 2 years
William Morris, MD
MultiCare Health System
United States: Food and Drug Administration
|MultiCare Health System Research Institute||Tacoma, Washington 98405|