A 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.
|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 Glial Tumors of the Brain|
- Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively [ Time Frame: participants will be followed while in the hospital and for 12 weeks after surgery ] [ Designated as safety issue: Yes ]
- Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA [ Time Frame: participants will be followed for 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||March 2015|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
5-Aminolevuline Acid (ALA)
Drug: 5-Aminolevuline Acid
5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before 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.
|United States, Oregon|
|Legacy Health System|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Jefferson Chen, MD, PhD||Legacy Health System|