Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | August 2015 |
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.
A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible
under ultraviolet light which allow the surgeon to see more of the tumor for a more complete
removal.
under ultraviolet light which allow the surgeon to see more of the tumor for a more complete
removal.
Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial.
Each patient will have been evaluated and found to have such a tumor by history and recent
imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical
standards of care.
Each patient will have been evaluated and found to have such a tumor by history and recent
imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical
standards of care.
Inclusion Criteria:
- Suspected primary brain tumor
- 18 years of age or more
- Normal marrow and organ function
- Life expectancy not a consideration
Exclusion Criteria:
- Receiving any other investigational agents
- History of allergic reactions to ALA
- Personal or family history of porphyrias
- Liver disease in the past year
- Uncontrolled intercurrent illness
- Pregnant or lactating women
- Inability to undergo MRI with contrast
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