Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2015
CompletedApril 12, 2019
September 1, 2015
5.6 years
August 17, 2009
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
More complete resection of malignant brain tumors
3-7 days
Secondary Outcomes (1)
Safety of drug
1 month
Study Arms (1)
Single-Arm
OTHERSingle-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.
Interventions
20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery
Eligibility Criteria
You may qualify if:
- Suspected primary brain tumor
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Matthew R Quigleylead
- DUSA Pharmaceuticals, Inc.collaborator
Study Sites (1)
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew R Quigley, MD
The Guthrie Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- administrator
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 18, 2009
Study Start
September 1, 2009
Primary Completion
April 22, 2015
Study Completion
April 23, 2015
Last Updated
April 12, 2019
Record last verified: 2015-09