Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
Conditions
Primary Glial Neoplasms of Brain - Glioblastoma
Conditions: official terms
Brain Neoplasms - Glioma
Conditions: Keywords
Brain tumor, glioma, surgical resection, ALA, ultraviolet light
Study Type
Interventional
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
Intervention
Name: Aminolevulinic Acid Type: Drug
Name: Aminolevulinic Acid Type: Drug
Overall Status
Recruiting
Summary
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
Location
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
Sponsors
West Penn Allegheny Health System
Source
West Penn Allegheny Health System
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page