Back to resultsFluorescence Spectroscopy Guided Surgery (GLIOSPECT)
Primary Purpose
Low Grade Glioma (LGG), High Grade Glioma (HGG)
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Fluorescence spectroscopy guided surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Low Grade Glioma (LGG) focused on measuring glioma, fluorescence spectroscopy
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:
- 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
Intraoperative fluorescence spectroscopy
Arm Description
The experimental device will be assessed during an open surgical approach for surgical removal of the tumors
Outcomes
Primary Outcome Measures
Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm
The technical feasibility will be assessed by the capacity of the prototype to provide distinguished fluorescence emission spectrum depending on the tumor component (correlation between the spectrum and classical histology).
Secondary Outcome Measures
Assessment of the safety as a composite outcome measure : number, type and severity of recorded adverse events
Safety will be assessed by the number, type and severity of recorded adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02473380
Brief Title
Fluorescence Spectroscopy Guided Surgery
Acronym
GLIOSPECT
Official Title
Fluorescence Spectroscopy Guided Surgery for Brain Tumors Resection: a Feasibility Study in Human
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (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
Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. This innovative method could become in future 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. However, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.
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, fluorescence spectroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative fluorescence spectroscopy
Arm Type
Experimental
Arm Description
The experimental device will be assessed during an open surgical approach for surgical removal of the tumors
Intervention Type
Device
Intervention Name(s)
Fluorescence spectroscopy guided surgery
Intervention Description
A prototype of intraoperative fluorescence spectroscope will be used for fluorescence spectroscopy during a surgical procedure (open surgical approach only). The experimental probe dedicated to the spectroscopic system will be positioned against the surface of the brain, emission spectrum will be acquired and measured, and finally compared with anatomopathology exams. One specific medication will be used as contrast agent in the study: 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.
Primary Outcome Measure Information:
Title
Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm
Description
The technical feasibility will be assessed by the capacity of the prototype to provide distinguished fluorescence emission spectrum depending on the tumor component (correlation between the spectrum and classical histology).
Time Frame
1 day (End of the surgical procedure)
Secondary Outcome Measure Information:
Title
Assessment of the safety as a composite outcome measure : number, type and severity of recorded adverse events
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
19 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:
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
Jacques GUYOTAT, MD, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/16648043
Description
Stummer et al. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol 2006 May;7(5):392-401
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=23318102
Description
Jacquesson et al. [Surgery of high-grade gliomas guided by fluorescence: a retrospective study of 22 patients]. Neurochirurgie. 2013 Feb;59(1):9-16.
URL
http://www.ncbi.nlm.nih.gov/pubmed/23577290
Description
Montcel et al. Two-peaked 5-ALA-induced PpIX fluorescence emission spectrum distinguishes glioblastomas from low grade gliomas and infiltrative component of glioblastomas. Biomed Opt Express. 2013 Apr 1;4(4):548-58
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Fluorescence Spectroscopy Guided Surgery
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