drugset / Trial / NCT02119338
5-ALA in Recurrent Glioma
NaSingle-groupOpen-labelDiagnostic
Summary
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.
Timeline
- Start
- 2014-02
- Primary completion
- 2017-06
- Completion
- 2017-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 5 mg/kg | Oral |
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 10 mg/kg | Oral |
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 20 mg/kg | Oral |