Clinical trial NCT04280952: Confocal Laser Endomicroscopy for Brain Tumors
Official title: Confocal Laser Endomicroscopy for Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Surgery
Convivo System
Laser Endomicroscopy
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Tumor tissue identification with CONVIVO system
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of tumor tissue
timeFrame: End of surgery
Secondary outcomes:
measure: Accuracy of CONVIVO results
timeFrame: 14 days after surgery
measure: Time for tissue visualization with the CONVIVO system
timeFrame: End of surgery
measure: Rate of unclear visualizations
timeFrame: 14 days after surgery
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Neurosurgery, Bern University Hospital
Study officials:
affiliation: Principal Investigator
name: Kathleen Seidel, MD
role: PRINCIPAL_INVESTIGATOR
References: