Clinical trial · Interventional
Confocal Laser Endomicroscopy for Brain Tumors
- 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 prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification. In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy. CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of differentiating various tumor entities in animal models as well as human tissue samples. CLE allows visualization of the underlying tissue on a microscopic scale, receiving information on the microstructure as well as cellular components. However, the clinical importance of this technique for its application in neurosurgery will be demonstrated in this clinical trial.
Conditions
Conditions (4)
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 |
| Convivo System | — | UNRESOLVED | — |
| Laser Endomicroscopy | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONVIVO | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CONVIVO
- description
- tumor tissue identification with the CONVIVO system
- interventionNames
- Device: CONVIVO
Primary outcomes (1)
- measure
- Identification of tumor tissue
- timeFrame
- End of surgery
- description
- Identification of tumor tissue versus non-affected tissue by the CONVIVO system in comparison to the histopathology of frozen section
Secondary outcomes (3)
- measure
- Accuracy of CONVIVO results
- timeFrame
- 14 days after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is undergoing neurosurgery for a suspected brain tumor and amenable to surgical resection by fluorescent guided technique * The patient has an indication for tumor resection * Macroscopic tumor visualization using sodium fluorescein is planned, concentration 5-10mg/kg * The patient is older than 18 years * Written consent Exclusion Criteria: * Stereotactic biopsy procedure * Patients with any kind of contraindication to the use of fluorescein sodium * Vulnerable persons (pregnant women, patients with Glasgow Coma Scale below 14) * Participation in other ongoing clinical trials with one exception: double inclusions are allowed provided that no interaction with NaF is to be expected * People who do not want to participate in the study * Tumors that do not exactly match the inclusion criteria * Emergency procedures in which no consent was obtained before the operation. * Multiple surgeries on the same patient.
References
Publications (0)
Data not yet available