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Confocal Laser Endomicroscopy for Brain Tumors (CONVIVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280952
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Brain Tumor Surgery Convivo System Laser Endomicroscopy Device: CONVIVO Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Tumor tissue identification with CONVIVO system
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Confocal Laser Endomicroscopy for Brain Tumors
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: CONVIVO
tumor tissue identification with the CONVIVO system
Device: CONVIVO
tumor tissue with the CONVIVO system




Primary Outcome Measures :
  1. Identification of tumor tissue [ Time Frame: End of surgery ]
    Identification of tumor tissue versus non-affected tissue by the CONVIVO system in comparison to the histopathology of frozen section


Secondary Outcome Measures :
  1. Accuracy of CONVIVO results [ Time Frame: 14 days after surgery ]
    Accuracy of CONVIVO results compared with results of final tumor histopathology

  2. Time for tissue visualization with the CONVIVO system [ Time Frame: End of surgery ]
    Intraoperative time for the tissue visualization with the CONVIVO system

  3. Rate of unclear visualizations [ Time Frame: 14 days after surgery ]
    Rate of unclear visualizations in %



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280952


Contacts
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Contact: Kathleen Seidel, MD +41316322409 kathleen.seidel@insel.ch
Contact: Zbinden Chantal +41316328354 chantal.zbinden@insel.ch

Locations
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Switzerland
Dep. of Neurosurgery, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Kathleen Seidel, MD    +41316322409    kathleen.seidel@insel.ch   
Contact: Chantal Zbinden    +41316328354    chantal.zbinden@insel.ch   
Principal Investigator: Kathleen Seidel, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Kathleen Seidel, MD Principal Investigator
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04280952    
Other Study ID Numbers: CONVIVO
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases