Clinical trial · Interventional
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.
NCT00961090CI-TRIAL-00038102completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid | Drug | Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single-Arm
- description
- Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.
- interventionNames
- Drug: Aminolevulinic Acid
Primary outcomes (1)
- measure
- More complete resection of malignant brain tumors
- timeFrame
- 3-7 days
Secondary outcomes (1)
- measure
- Safety of drug
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected primary brain tumor * 18 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.