Status:
COMPLETED
Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
Lead Sponsor:
Matthew R Quigley
Collaborating Sponsors:
DUSA Pharmaceuticals, Inc.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Suspected primary brain tumor
- 18 years of age or more
- Normal marrow and organ function
- Eastern Cooperative Group performance status ≤ 2
- Women of childbearing potential must use adequate birth control
- Ability to understand and willingness to sign a written informed consent form
- Life expectancy not a consideration
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00961090
Start Date
September 1 2009
End Date
April 23 2015
Last Update
April 12 2019
Active Locations (1)
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1
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212