Clinical trial NCT02473380: Fluorescence Spectroscopy Guided Surgery
Official title: Fluorescence Spectroscopy Guided Surgery for Brain Tumors Resection: a Feasibility Study in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Grade Glioma (LGG)
High Grade Glioma (HGG)
Keywords: glioma
fluorescence spectroscopy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm
timeFrame: 1 day (End of the surgical procedure)
Secondary outcomes:
measure: Assessment of the safety as a composite outcome measure : number, type and severity of recorded adverse events
timeFrame: 14 days after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Jacques GUYOTAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: