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Confocal Laser Endomicroscopy for Brain Tumors (GLIOFOCAL)

Primary Purpose

Low Grade Glioma (LGG), High Grade Glioma (HGG)

Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Grade Glioma (LGG), High Grade Glioma (HGG) focused on measuring glioma, confocal laser endomicroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18 years old
  • Clinical signs and history of the disease in favor of a HGG, LGG
  • MRI study in favor of a HGG, LGG, meningioma or brain metastasis
  • Affiliated to or beneficiary of a social security system (or equivalent).
  • Patients who have provided written informed consent for the study

Exclusion Criteria:

  • - Allergy to fluorescein
  • Previous life-threatening allergic reactions and known hypersensitivity
  • Pregnant or lactating or not using effective contraception;
  • Restricted renal function define by a creatinine clearance < 30ml/min
  • Patients under a beta-blockers treatment
  • Contraindication to do an MRI (pace-maker)
  • Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria
  • Minor or adult ward of court (under guardianship or trusteeship)
  • No affiliation to a social security system (or equivalent).
  • Patients who express opposition to participation in the study.

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surgical removal of the tumors+stereotaxic biopsy

Arm Description

Outcomes

Primary Outcome Measures

To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.
The technical feasibility will be assessed by the capacity of the CELLVIZIO® system to provide microscopic images of healthy tissue and lesions suspected with malignancy and to match those images with classical histologies.

Secondary Outcome Measures

To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.
Safety will be assessed by the number, type and severity of recorded adverse events.

Full Information

First Posted
September 12, 2014
Last Updated
November 25, 2015
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02240758
Brief Title
Confocal Laser Endomicroscopy for Brain Tumors
Acronym
GLIOFOCAL
Official Title
INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. Probe-based CLE using the CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the potential of this technique in improving surgical resection outcome, a feasability study has to be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Glioma (LGG), High Grade Glioma (HGG)
Keywords
glioma, confocal laser endomicroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgical removal of the tumors+stereotaxic biopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)
Intervention Description
The CELLVIZIO® system (Mauna Kea technology) will be used for confocal endomicroscopy during a surgical procedure (either open surgical approach or stereotaxic biopsy). The probe dedicated to the CELLVIZIO® system will be positioned against the surface of the brain, sequences will be acquired, and finally compared with anatomapathology exams. Two specific medications will be used as contrast agent in the study: Fluorescein FAURE 500mg/5mL IV with a maximum of two doses per patient OR 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.
Primary Outcome Measure Information:
Title
To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.
Description
The technical feasibility will be assessed by the capacity of the CELLVIZIO® system to provide microscopic images of healthy tissue and lesions suspected with malignancy and to match those images with classical histologies.
Time Frame
End of the surgical procedure
Secondary Outcome Measure Information:
Title
To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.
Description
Safety will be assessed by the number, type and severity of recorded adverse events.
Time Frame
14 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years old Clinical signs and history of the disease in favor of a HGG, LGG MRI study in favor of a HGG, LGG, meningioma or brain metastasis Affiliated to or beneficiary of a social security system (or equivalent). Patients who have provided written informed consent for the study Exclusion Criteria: - Allergy to fluorescein Previous life-threatening allergic reactions and known hypersensitivity Pregnant or lactating or not using effective contraception; Restricted renal function define by a creatinine clearance < 30ml/min Patients under a beta-blockers treatment Contraindication to do an MRI (pace-maker) Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria Minor or adult ward of court (under guardianship or trusteeship) No affiliation to a social security system (or equivalent). Patients who express opposition to participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GUYOTAT JACQUES, MD, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France

12. IPD Sharing Statement

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Confocal Laser Endomicroscopy for Brain Tumors

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