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Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
This study has been completed.
Sponsor:
Diane Cantella
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Diane Cantella, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier:
NCT00961090
First received: August 17, 2009
Last updated: September 21, 2015
Last verified: September 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Glioblastoma | Drug: Aminolevulinic Acid | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by Diane Cantella, Allegheny Singer Research Institute:
Primary Outcome Measures:
- More complete resection of malignant brain tumors [ Time Frame: 3-7 days ]
Secondary Outcome Measures:
- Safety of drug [ Time Frame: 1 month ]
| Enrollment: | 150 |
| Study Start Date: | September 2009 |
| Study Completion Date: | August 2015 |
| Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Aminolevulinic Acid
20 mg/kg mixed in water and taken orally prior to surgery
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.
Eligibility| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | August 17, 2009 |
| Last Updated: | September 21, 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 |
ClinicalTrials.gov processed this record on September 21, 2017