cropped color_logo_with_background.png

Confocal Laser Endomicroscopy for Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04280952
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Insel Gruppe AG, University Hospital Bern
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kathleen Seidel, MD
Principal Investigator Affiliation Principal Investigator
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor, Surgery, Convivo System, Laser Endomicroscopy
Additional Details

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.

Arms & Interventions

Arms

Experimental: CONVIVO

tumor tissue identification with the CONVIVO system

Interventions

Device: - CONVIVO

tumor tissue with the CONVIVO system

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bern, Switzerland

Status

Address

Dep. of Neurosurgery, Bern University Hospital

Bern, , 3010