Confocal Laser Endomicroscopy for Brain Tumors

NCT04280952 | Completed

• 1 other identifier: CONVIVO
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Surgery; Convivo System; Laser Endomicroscopy

Outcome Measures

Primary Outcomes (1)

• Identification of tumor tissue

  Identification of tumor tissue versus non-affected tissue by the CONVIVO system in comparison to the histopathology of frozen section

  End of surgery

Secondary Outcomes (3)

• Accuracy of CONVIVO results

  14 days after surgery

• Time for tissue visualization with the CONVIVO system

  End of surgery

• Rate of unclear visualizations

  14 days after surgery

Study Arms (1)

CONVIVO

EXPERIMENTAL

tumor tissue identification with the CONVIVO system

Device: CONVIVO

Interventions

CONVIVO DEVICE

tumor tissue with the CONVIVO system

CONVIVO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• People who do not want to participate in the study
• Emergency procedures in which no consent was obtained before the operation.
• Multiple surgeries on the same patient.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kathleen Seidel, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Tumor tissue identification with CONVIVO system

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 21, 2020
• Study Start: June 5, 2020
• Primary Completion: June 13, 2023
• Study Completion: June 30, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)