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

Matthew R Quigley72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma

Interventions

Aminolevulinic AcidDRUG

20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

More complete resection of malignant brain tumors

Time frame: 3-7 days

Secondary Outcomes

Safety of drug

Time frame: 1 month

Data from ClinicalTrials.gov

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