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NCT02473380: GLIOSPECT
Fluorescence Spectroscopy Guided Surgery for Brain Tumors Resection: a Feasibility Study in Human
Phase 1 trial testing Fluorescence spectroscopy guided surgery in Low Grade Glioma (LGG) in 11 participants. Completed in 1 October 2016.
1 October 2016
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 11 |
| Start date | 1 August 2015 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 October 2016 |
| Sites | 1 location across France |
Drugs / interventions tested
- Fluorescence spectroscopy guided surgery
Conditions studied
- Low Grade Glioma (LGG) — all drugs for Low Grade Glioma (LGG) →
- High Grade Glioma (HGG) — all drugs for High Grade Glioma (HGG) →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
19 and older, any sex, with Low Grade Glioma (LGG) or High Grade Glioma (HGG). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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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).
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Optical imaging probes in oncology.
Martelli C, Lo Dico A, Diceglie C, Lucignani G, et al · · 2016 · cited 32× · PMID 27145373 · DOI 10.18632/oncotarget.9066
Verify or expand the search:
- PubMed search for NCT02473380
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02473380 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 21 May 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 13 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02473380.