Clinical trial · Interventional
5-ALA in Recurrent Glioma
Barrow ALA Trial for Recurrent Gliomas
- 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)
The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.
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-ala | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-ala preoperatively
- description
- A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery.
- interventionNames
- Drug: 5-ala
Primary outcomes (1)
- measure
- Presence of fluorescence in tumor tissue compared to tissue with treatment effect.
- timeFrame
- day of surgery-1 day
- description
- Correlation of fluorescence with pathological findings
Secondary outcomes (3)
- measure
- Extent of resection
- timeFrame
- time within 48 hours post operative
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Presumed recurrent glioma * Age \> 18 years * Normal bone marrow function (WBC \> 3000, Platelets \> 100,000) Exclusion Criteria * Pregnancy * History of photosensitivity, porphyria, or exfoliative dermatitis * Hepatic dysfunction in the last 12 months \[defined by aspartate aminotransferase(AST), alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin \> 2.5 x normal\] * Serum creatinine \> 180 µmol/L * Estimated Glomerular Filtration Rate (eGFR)\< 60 ml/min/1.73m2 * Inability to undergo MRI with contrast
References
Publications (0)
Data not yet available