Fluorescence Spectroscopy Guided Surgery (GLIOSPECT)

December 13, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69002
        • Hospices civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative fluorescence spectroscopy
The experimental device will be assessed during an open surgical approach for surgical removal of the tumors
Device: 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.

What is the study measuring?

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
Time Frame: 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).
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
Time Frame: 14 days after inclusion
Safety will be assessed by the number, type and severity of recorded adverse events.
14 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jacques GUYOTAT, MD, PhD, Hospices civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimated)

June 16, 2015

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL14-0270

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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