Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
Primary Glial Neoplasms of Brain - Glioblastoma
Conditions: official terms
Brain Neoplasms - Glioma
Conditions: Keywords
Brain tumor, glioma, surgical resection, ALA, ultraviolet light
Study Type
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Aminolevulinic Acid Type: Drug
Name: Aminolevulinic Acid Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 prophorias

- Liver disease in the past year

- Uncontrolled intercurrent illness

- Pregnant or Lactating women

- Inability to undergo MRI with contrast
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Dorothy M Packer, RN, BSN - 412-359-6505
Start Date
September 2009
Completion Date
October 2013
West Penn Allegheny Health System
West Penn Allegheny Health System
Record processing date processed this data on July 28, 2015 page