Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Tumors of the Brain
The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to visualize and thus able to make a complete, or near-complete resection of the tumor.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Tumors of the Brain|
- To determine if the use of 5-aminolevulinic acid (ALA) helps distinguish tumor cells [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Determine the safety of 5-aminolevulinic acid (ALA) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Determine the safety of a single dose of 5-aminolevulinic acid (ALA) administered preoperatively at a dose of 20 mg/kg body weight.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Drug: 5-Aminolevuline Acid
Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116661
|Contact: Silvia Gonzalez, BSemail@example.com|
|Contact: Valerie A Kivett, BS||415-353-2076||Kivettv@neurosurg.ucsf.edu|
|United States, California|
|UCSF Department of Neurosurgery||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Silvia Gonzalez, BS 415-353-2523 firstname.lastname@example.org|
|Contact: Valerie A Kivett, BS 415-353-2076 email@example.com|
|Principal Investigator: Mitchel S Berger, MD|
|Sub-Investigator: Michael Prados, MD|
|Sub-Investigator: Susan S Chang, MD|
|Sub-Investigator: Nicholas Butowski, MD|
|Sub-Investigator: Jennifer Clarke, MD, MPH|
|Principal Investigator:||Mitchel S Berger, MD||UCSF Department of Neurosurgery|