Confocal Laser Endomicroscopy for Brain Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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Background: 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 still needs to be demonstrated Methods: Intravenous injection dose of fluorescein sodium. For every operation the investigators plan to take pictures with the CONVIVO system before taking the material for standard frozen section and definitive histopathology. These pictures will be evaluated by a pathologist afterwards. Objectives: The primary objective of this trial is to demonstrate, that the CONVIVO system allows identification of tumor tissue. The secondary objectives are procedural aspects and handling issues covering the usability.

Official Title
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Confocal Laser Endomicroscopy for Brain Tumors

Conditions
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Surgery, Brain Tumor, Convivo System, Laser Endomicroscopy

Intervention / Treatment
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* Device: CONVIVO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Tumor tissue identification with CONVIVO system
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CONVIVO<br>tumor tissue identification with the CONVIVO system | Device: CONVIVO<br>* tumor tissue with the CONVIVO system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of tumor tissue | Identification of tumor tissue versus non-affected tissue by the CONVIVO system in comparison to the histopathology of frozen section | End of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of CONVIVO results | Accuracy of CONVIVO results compared with results of final tumor histopathology | 14 days after surgery | 
| Time for tissue visualization with the CONVIVO system | Intraoperative time for the tissue visualization with the CONVIVO system | End of surgery | 
| Rate of unclear visualizations | Rate of unclear visualizations in % | 14 days after surgery |