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

• Status: Completed
• Trial end date: 2015-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diane Cantella; Matthew R Quigley
• Collaborator: DUSA Pharmaceuticals, Inc.
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• 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 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