Fluorescence Spectroscopy Guided Surgery

Phase 1

Completed

• Conditions: Low Grade Glioma (LGG); High Grade Glioma (HGG)
• Interventions: Device: Fluorescence spectroscopy guided surgery

• Registration Number: NCT02473380
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-16
• Study Start: 2015-08
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative fluorescence spectroscopy	Fluorescence spectroscopy guided surgery	The experimental device will be assessed during an open surgical approach for surgical removal of the tumors

Primary Outcome Measures

Name	Time	Method
Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm	1 day (End of the surgical procedure)	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

Name	Time	Method
Assessment of the safety as a composite outcome measure : number, type and severity of recorded adverse events	14 days after inclusion	Safety will be assessed by the number, type and severity of recorded adverse events.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France