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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00961090
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Aminolevulinic Acid Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.
Study Start Date : September 2009
Primary Completion Date : August 2015
Study Completion Date : August 2015


Arms and Interventions

Intervention Details:
    Drug: Aminolevulinic Acid
    20 mg/kg mixed in water and taken orally prior to surgery

Outcome Measures

Primary Outcome Measures :
  1. More complete resection of malignant brain tumors [ Time Frame: 3-7 days ]

Secondary Outcome Measures :
  1. Safety of drug [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected primary brain tumor
  • 18 years of age or more
  • Normal marrow and organ function
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961090


Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Diane Cantella
DUSA Pharmaceuticals, Inc.
Investigators
Principal Investigator: Matthew R Quigley, MD The Guthrie Clinic
More Information

Responsible Party: Diane Cantella, co-investigator, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier: NCT00961090     History of Changes
Other Study ID Numbers: 104974
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Diane Cantella, Allegheny Singer Research Institute:
Brain tumor
glioma
surgical resection
ALA
ultraviolet light

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents