Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
- Registration Number
- NCT00961090
- Lead Sponsor
- Matthew R Quigley
- 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 (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-Arm Aminolevulinic Acid Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.
- Primary Outcome Measures
Name Time Method More complete resection of malignant brain tumors 3-7 days
- Secondary Outcome Measures
Name Time Method Safety of drug 1 month
Trial Locations
- Locations (1)
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States