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

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ClinicalTrials.gov Identifier: NCT00961090
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Matthew R Quigley, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
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
Actual Primary Completion Date : April 22, 2015
Actual Study Completion Date : April 23, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Arm Intervention/treatment
Single-Arm
Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.
 Drug: Aminolevulinic Acid
20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery
Other Name: ALA


Outcome Measures
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • 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
Contacts and Locations
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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
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United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Matthew R Quigley
DUSA Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Matthew R Quigley, MD The Guthrie Clinic
More Information
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Responsible Party: Matthew R Quigley, administrator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT00961090    
Other Study ID Numbers: 104974
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: September 2015
Keywords provided by Matthew R Quigley, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute):
Brain tumor
glioma
surgical resection
ALA
ultraviolet light
Additional relevant MeSH terms:
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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