Fluorescence Spectroscopy Guided Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Fluorescence Spectroscopy Guided Surgery for Brain Tumors Resection: a Feasibility Study in Human

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

Intervention / Treatment
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* Device: Fluorescence spectroscopy guided surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative fluorescence spectroscopy<br>The experimental device will be assessed during an open surgical approach for surgical removal of the tumors | Device: Fluorescence spectroscopy guided surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 day (End of the surgical procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioma, fluorescence spectroscopy