Clinical trial · Interventional
Fluorescence-guided Surgery for Low- and High-grade Gliomas
Barrow 5-ALA Intraoperative Confocal Evaluation Trial
- 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)
Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat. Mounting evidence suggests that survival improves with greater tumor removal, yet being able do a complete removal can be difficult due to the tumor's infiltrating nature. 5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3 hours before surgery, is selectively taken up by glioma cells and causes a red/pink fluorescence (glow) under a blue light that allows tumor margins to be seen during the course of surgery. While this compound is used as a standard-of-care agent in Europe, it remains under testing by the Food and Drug Administration (FDA). A recent clinical trial in Germany, however, has demonstrated a significant improvement in the rate of complete resection for certain brain tumors (65% vs. 34%). The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the special microscope during surgery will greatly lower the amount of tumor left behind.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevulinic acid (ALA) | Drug | 5-Aminolevulinic Acid | ALIAS |
| Placebo - ascorbic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5-ALA/Gliolan® /5-Aminolevulinic acid
- description
- Within 3 hours prior to surgery, patient will orally ingest \[or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)\] 5-ALA/Gliolan®/5-Aminolevulinic acid mixed with sterile water (20mg/kg)
- interventionNames
- Drug: 5-Aminolevulinic acid (ALA)
- type
- PLACEBO_COMPARATOR
- label
- Placebo - ascorbic acid
- description
- Within 3 hours prior to surgery, patient will orally ingest \[or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)\] 1.5 Gm. placebo - ascorbic acid in 50 ml sterile water.
- interventionNames
- Drug: Placebo - ascorbic acid
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Presumed newly-diagnosed supratentorial glioma (previous biopsy-only/no adjuvant therapy are eligible for randomization) * Age \> 18 years * Normal bone marrow function (WBC \> 3000, Platelets \> 100,000) Exclusion Criteria: * Infratentorial tumors * Pregnancy * Hypersensitivity to 5-aminolevulinic acid hydrochloride or porphyrins * History of photosensitivity, porphyria, or exfoliative dermatitis * Hepatic dysfunction in the last 12 months (defined by AST, ALT, ALP, bilirubin \> 2.5 x normal) * Serum creatinine \> 180 µmol/L * Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2 * Inability to undergo MRI scan with contrast
References
Publications (1)
- RESULTSanai N, Snyder LA, Honea NJ, Coons SW, Eschbacher JM, Smith KA, Spetzler RF. Intraoperative confocal microscopy in the visualization of 5-aminolevulinic acid fluorescence in low-grade gliomas. J Neurosurg. 2011 Oct;115(4):740-8. doi: 10.3171/2011.6.JNS11252. Epub 2011 Jul 15. PMID 21761971