Clinical trial · Observational
Confocal Laser Endomicroscopy (CLE) During Medically Induced Neurosurgery in Craniobasal and Glioma Tumours
Adjoint Intra-operative Confocal Laser Endomicroscopy (CLE) to Present Tissue on the Cellular Level in Defined Lesions of the Central Nervous System (CNS) During Medically Induced Neurosurgery in Subcranial Tumors and Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped by local authorities
Summary
Brief summary (as posted)
Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of CLE during neurosurgical procedures
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 |
|---|---|---|---|
| Cerebral Tumors | Cerebral Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cellvizio mini laser probe | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cellvizio mini laser probe
- description
- Cellvizio mini laser probe will be administered via the endoscopic device used for the neurosurgical procedure to provide confocal laser endomicroscopy in patients requiring neurosurgery due to glioma multiforme or subcranial tumors
- interventionNames
- Other: Cellvizio mini laser probe
Primary outcomes (1)
- measure
- post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology
- timeFrame
- duration of hospital stay, an expected average of 7 days
Secondary outcomes (3)
- measure
- proof of complete removal of pathologic tissue within healthy tissue
- timeFrame
- during surgical procedure, an expected average time of three hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * patients administered to the department of neurosurgery requiring neurosurgery due to either diagnosed gliomata (40 patients) or diagnosed subcranial tumors adjacent to or already invading neuronal structures (20 patients) * patients having given informed consent Exclusion Criteria: * severe concomitant diseases probably negatively influencing the participation in this clinical trial * cardial infarction or stroke within the preceding 12 months * Treatment resistant hypertonus (systolic blood pressure \>200 mmHg or diastolic blood pressure \>120 mmHg or a combination of both * Pulmonic diseases that might result in an advanced risk for anesthetic measurements * Patients being vaccinated with live vaccines (14 days Prior) or contra Influenza (7 days Prior) to start of the study * All concomitant findings that might increase in the eyes of the investigator the risk of participation
References
Publications (0)
Data not yet available