Fluorescence Spectroscopy Guided Surgery
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 19 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02473380 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Hospices Civils de Lyon |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Jacques GUYOTAT, MD, PhD |
| Principal Investigator Affiliation | Hospices Civils de Lyon |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Completed |
| Countries | France |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Low Grade Glioma (LGG), High Grade Glioma (HGG) |
| Study Website: | View Trial Website |
Contact a Trial Team
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