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Fluorescence Spectroscopy Guided Surgery

NCT ID: NCT02473380

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-10-31

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.

Detailed Description

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Conditions

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

Keywords

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glioma fluorescence spectroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intraoperative fluorescence spectroscopy

The experimental device will be assessed during an open surgical approach for surgical removal of the tumors

Group Type EXPERIMENTAL

Fluorescence spectroscopy guided surgery

Intervention Type DEVICE

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.

Interventions

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Fluorescence spectroscopy guided surgery

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.

Intervention Type DEVICE

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques GUYOTAT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

References

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Alston L, Mahieu-Williame L, Hebert M, Kantapareddy P, Meyronet D, Rousseau D, Guyotat J, Montcel B. Spectral complexity of 5-ALA induced PpIX fluorescence in guided surgery: a clinical study towards the discrimination of healthy tissue and margin boundaries in high and low grade gliomas. Biomed Opt Express. 2019 Apr 18;10(5):2478-2492. doi: 10.1364/BOE.10.002478. eCollection 2019 May 1.

Reference Type RESULT
PMID: 31149380 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/16648043

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

http://www.ncbi.nlm.nih.gov/pubmed/?term=23318102

Jacquesson et al. \[Surgery of high-grade gliomas guided by fluorescence: a retrospective study of 22 patients\]. Neurochirurgie. 2013 Feb;59(1):9-16.

http://www.ncbi.nlm.nih.gov/pubmed/23577290

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

Other Identifiers

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69HCL14-0270

Identifier Type: -

Identifier Source: org_study_id