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
18 Years
N/A
Open (Enrolling)
Both
Primary Glial Neoplasms of Brain, Glioblastoma
Both
Primary Glial Neoplasms of Brain, Glioblastoma
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 Hospital | Pittsburgh, Pennsylvania 15212-4772 |
