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

Matthew R Quigley

Status and phase: Completed; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Aminolevulinic Acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00961090

104974

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Single-Arm

Other group

Description:

Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.

Treatment:

Drug: Aminolevulinic Acid