Clinical trial · Interventional
Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The primary objective for high grade gliomas has been met and the FDA has now approved the drug (Gleolan) for use in the United States.
Summary
Brief summary (as posted)
The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to visualize and thus able to make a complete, or near-complete resection of the tumor.
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 |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevuline Acid (ALA) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALA for glioma (WHO G1-IV) subjects
- description
- Up to 300 patients with diagnosed glioma (WHO G1-IV) eligible for surgery will be entered into the trial and will be given 5-Aminolevulinic Acid (ALA) orally at a dose of 20mg/kg body weight preoperatively
- interventionNames
- Drug: 5-Aminolevuline Acid (ALA)
Primary outcomes (1)
- measure
- The Percentage of Biopsies Taken From the Most Fluorescent Tissues That Have Tumorous Content.
- timeFrame
- 1 day
- description
- Biopsies were examined by a pathologist to determine the amount of tumor content from the most fluorescent tissues
Secondary outcomes (1)
- measure
- Number of Participants With Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: 1. Presumptive diagnosis of high grade or low grade glioma based on imaging studies, or will have recurrent high-grade or low grade gliomas that have previously undergone diagnosis (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme). Both of these groups will be undergoing craniotomy for tumor resection. 2. Patient age 18 to 72 years. 3. Karnofsky performance of 60% or greater 4. Patients must have normal organ and marrow function as defined below: Leukocytes \>3,000/μL Absolute neutrophil count \>1,500/μL Platelets \>100,000/μL Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT) \<2.5 X institutional upper limit of normal Creatinine within normal institutional limits or Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 5. The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown. Therefore, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 6. Patient must have the ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign the written informed consent. Exclusion Criteria: 1. Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). 2. Subjects with a history or family history of Porphyrias 3. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Pregnancy.
References
Publications (1)
- DERIVEDWidhalm G, Olson J, Weller J, Bravo J, Han SJ, Phillips J, Hervey-Jumper SL, Chang SM, Roberts DW, Berger MS. The value of visible 5-ALA fluorescence and quantitative protoporphyrin IX analysis for improved surgery of suspected low-grade gliomas. J Neurosurg. 2019 May 10;133(1):79-88. doi: 10.3171/2019.1.JNS182614. Print 2020 Jul 1. PMID 31075771