Clinical trial · Observational
Fluorescence Enhanced Stereotactic Surgery (FESS)
Fluorescence Enhanced Stereotactic Surgery
- 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)
Histopathological diagnosis is essential for gliomas, but stereotactic biopsy carries significant risks and can fail to provide diagnostic tissue. This study aims to develop and validate an advanced fiber optic system integrated into a standard Nashold biopsy needle. This system combines 5-ALA fluorescence, Raman spectroscopy, and ultrasound imaging to provide real-time feedback on tumor tissue and blood vessels. The study involves ex-vivo testing on brain tumor tissues (High Grade Glioma) obtained through surgical resection to validate the system's ability to identify tumor margins and vascular structures, aiming to improve biopsy safety and accuracy.
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 |
|---|---|---|---|
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
| High Grade Glioma (III or IV) | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 5-ALA Fluorescence Detection Accuracy
- timeFrame
- Day of surgery (intra-operative ex-vivo analysis)
- description
- Evaluation of the probe's sensitivity and specificity in detecting 5-ALA fluorescence signals in ex-vivo tumor tissue compared to the gold standard (histopathology/microscope). Measured parameters: operating wavelength interval, resolution, power range.
Secondary outcomes (2)
- measure
- Blood Vessel Identification
- timeFrame
- Day of surgery
- description
- Ability of the probe (using ultrasound/Raman) to detect microvessels in the ex-vivo sample, correlated with histological microvessel density.
- measure
- Tumor Cell Density Correlation
- timeFrame
- Day of surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged 18 years or older * Patients able to provide the informed consentPresumptive diagnosis of high grade glioma * Patient whose surgery require the use of 5-ALA as standard of treatment Exclusion Criteria: * Patients who are not suitable for surgery * Patients unable to provide informed consent due to cognitive impairment or other reasons
References
Publications (0)
Data not yet available