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Confocal Laser Endomicroscopy for Brain Tumors (CONVIVO)

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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

Tracking Information
First Submitted Date  ICMJE February 20, 2020
First Posted Date  ICMJE February 21, 2020
Last Update Posted Date July 9, 2021
Actual Study Start Date  ICMJE June 5, 2020
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Accuracy of CONVIVO results [ Time Frame: 14 days after surgery ]
    Accuracy of CONVIVO results compared with results of final tumor histopathology
  • Time for tissue visualization with the CONVIVO system [ Time Frame: End of surgery ]
    Intraoperative time for the tissue visualization with the CONVIVO system
  • Rate of unclear visualizations [ Time Frame: 14 days after surgery ]
    Rate of unclear visualizations in %
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Confocal Laser Endomicroscopy for Brain Tumors
Official Title  ICMJE Confocal Laser Endomicroscopy for Brain Tumors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Tumor tissue identification with CONVIVO system
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Tumor
  • Surgery
  • Convivo System
  • Laser Endomicroscopy
Intervention  ICMJE Device: CONVIVO
tumor tissue with the CONVIVO system
Study Arms  ICMJE Experimental: CONVIVO
tumor tissue identification with the CONVIVO system
Intervention: Device: CONVIVO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathleen Seidel, MD +41316322409 kathleen.seidel@insel.ch
Contact: Zbinden Chantal +41316328354 chantal.zbinden@insel.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04280952
Other Study ID Numbers  ICMJE CONVIVO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen Seidel, MD Principal Investigator
PRS Account University Hospital Inselspital, Berne
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP