Confocal Laser Endomicroscopy for Brain Tumors

NCT ID: NCT04280952

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2023-06-30

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.

Conditions

Brain Tumor; Surgery; Convivo System; Laser Endomicroscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONVIVO

tumor tissue identification with the CONVIVO system

Group Type: EXPERIMENTAL

CONVIVO

Intervention Type: DEVICE

tumor tissue with the CONVIVO system

Interventions

CONVIVO

tumor tissue with the CONVIVO system

Intervention Type: DEVICE

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

• Emergency procedures in which no consent was obtained before the operation.
• Multiple surgeries on the same patient.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Seidel, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Dep. of Neurosurgery, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

CONVIVO

Identifier Type: -

Identifier Source: org_study_id