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OpenTrials
Completed

NCT Number: NCT00961090

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

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.

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Key information

Conditions

Glioblastoma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminolevulinic Acid

Drug

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

Other names: ALA

Primary outcomes

  1. More complete resection of malignant brain tumors

    Time frame: 3-7 days

Secondary outcomes

  1. Safety of drug

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Matthew R Quigley

Other

Collaborators

  • DUSA Pharmaceuticals, Inc.

Registry information

Official study title

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2009
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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