A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Tumors of the Brain
The drug, 5-aminolevulinic acid (ALA), which leads to intracellular accumulation of
fluorescent porphyrins in malignant gliomas will be used under investigation for
identification and resection of high grade gliomas. Surgery will be done using a modified
neurosurgical microscope, with a fluorescent kit that enables switching from the
conventional white light to a violet-blue excitation light for visualization during tumor
resection. If deemed safe by the neurosurgeon, any area of the resection bed determined to
be fluorescence-positive for tumor will be removed with appropriate designation of tissue
for histopathological evaluation. After this resection, additional fluorescence images will
be obtained and the process repeated until the image is negative for tumor. At all times,
the decision to resect will be limited by clinical judgment of safety.
The desire is that a more complete resection will occur due to the surgeon's ability to
better visualize and distinguish between tumor and normal tissue, and thus be able to remove
as much, or most of, the tumorous tissue, resulting in a better outcome for the patient, or
for future patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if the use of 5-aminolevulinic acid (ALA) helps distinguish tumor cells
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 malignant glioma.
Mitchel S Berger, MD
UCSF Department of Neurosurgery
United States: Food and Drug Administration
|UCSF Department of Neurosurgery||San Francisco, California 94143|