Clinical trial · Observational
Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for 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)
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients. This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevulinic Acid | Drug | 5-Aminolevulinic Acid | ALIAS |
| Orbeye surgical videomicroscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with known or suspected high grade gliomas
- interventionNames
- Device: Orbeye surgical videomicroscope
- Drug: 5-Aminolevulinic Acid
Primary outcomes (1)
- measure
- Compare Visualized Fluroescence within brain tumors
- timeFrame
- Surgery day one
- description
- 6 tissue samples will be obtained intraoperatively for each patient and assessed for 5-ALA visualization (strongly positive.weakly positive/negative). Tissue samples will be submitted for pathological assessment to determine whether tumor cells are present or absent. Visualization results will be evaluated against the pathology results (gold standard) to determine the sensitivity, specificity, positive predictive value and negative predictive value for 5-ALA visualizations with use of the ORBEYE system.
Secondary outcomes (2)
- measure
- Volume of Residual tumor
- timeFrame
- up to 48 hours after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade II or IV), new or recurrent. * Indication for craniotomy for removal of a suspected or recurrent brain tumor * Karnofsky Performance Scale \>/- 60% Exclusion Criteria: * Prophyria, hypersensitivity to porphyrins * Renal insufficiency as defined per protocol * Hepatic insufficiency as defined per protocol * Existing pregnancy (to be checked by a pregnancy test if of child-bearing age. * Nursing women or women using inadequate contraception
References
Publications (0)
Data not yet available