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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Primary Glial Neoplasms of Brain, Glioblastoma

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Trial Information

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


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 prophorias

- Liver disease in the past year

- Uncontrolled intercurrent illness

- Pregnant or Lactating women

- Inability to undergo MRI with contrast

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

More complete resection of malignant brain tumors

Outcome Time Frame:

3-7 days

Safety Issue:

No

Principal Investigator

Matthew R Quigley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Penn Allegheny Health System

Authority:

United States: Food and Drug Administration

Study ID:

104974

NCT ID:

NCT00961090

Start Date:

September 2009

Completion Date:

October 2013

Related Keywords:

  • Primary Glial Neoplasms of Brain
  • Glioblastoma
  • Brain tumor
  • glioma
  • surgical resection
  • ALA
  • ultraviolet light
  • Brain Neoplasms
  • Neoplasms
  • Glioblastoma
  • Glioma

Name

Location

Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772