Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

Completed · Phase 2

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT00961090

Run by

Matthew R Quigley

People needed

72

Starts

2009-09-01

Expected to finish

2015-04-23

Last updated by the study team

2019-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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