Skip to main content
OpenTrials
Completed

NCT Number: NCT02473380

Fluorescence Spectroscopy Guided Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Grade Glioma (LGG) Glioma High Grade Glioma (HGG) Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluorescence spectroscopy guided surgery

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: GLIOSPECT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2015
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.