Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
This study has been completed.
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Diane Cantella, Allegheny Singer Research Institute
First received: August 17, 2009
Last updated: September 21, 2015
Last verified: September 2015
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.
Drug: Aminolevulinic Acid
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.
Primary Outcome Measures:
- More complete resection of malignant brain tumors [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of drug [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Suspected primary brain tumor
- 18 years of age or more
- Normal marrow and organ function
- Life expectancy not a consideration
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961090
|Allegheny General Hospital
|Pittsburgh, Pennsylvania, United States, 15212 |
DUSA Pharmaceuticals, Inc.
||Matthew R Quigley, MD
||The Guthrie Clinic
No publications provided
||Diane Cantella, co-investigator, Allegheny Singer Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 17, 2009
||September 21, 2015
||United States: Food and Drug Administration
Keywords provided by Allegheny Singer Research Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2015