NCT02240758

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

1 month

First QC Date

September 12, 2014

Last Update Submit

November 25, 2015

Conditions

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

Keywords

glioma, confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    End of the surgical procedure

Secondary Outcomes (1)

  • To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.

    14 days after inclusion

Study Arms (1)

surgical removal of the tumors+stereotaxic biopsy

EXPERIMENTAL
Procedure: confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)

Interventions

confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)PROCEDURE

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.

surgical removal of the tumors+stereotaxic biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • GUYOTAT JACQUES, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

FR(1)