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Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors

Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03970785
Acronym
FLUOGOD
Enrollment
7
Registered
2019-06-03
Start date
2018-07-15
Completion date
2019-05-15
Last updated
2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

Keywords

fluorescein, gangliogliomas, glioneuronal, Dysembryoplastic Neuroepithelial Tumor

Brief summary

One of the key issues of tumour brain surgeries is to clearly define the borders of the tumor. The investigators proposed to evaluate the feasibility of intraoperative fluorescein guidance. Patients will be identified from the list of patients operated on under fluorescence to collect clinical datas. Surgical videos will be analyzed to assess the presence of intraoperative fluorescence and its subjectively judged intensity. MRI data will be extracted from the radiological reports to assess quality extraction. No additional data will be produced

Detailed description

Gangliogliomas typically present as a slow-growing, cystic mass taking contrast, while dysembryoplastic neuro-epithelial tumors commonly show microcystic patterns, inconstant contrast-enhancement and are preferentially located on the internal face of the temporal lobe. The cornerstone of the treatment of these two entities remains surgery, as it provides good oncological outcomes and control of seizures. Surgical resection keeps a major role for these tumors. Thus, one of the key issues is to clearly define the borders of the tumor during surgery, a point of considerable importance for these curable lesions. Then, the investigators proposed to evaluate the feasibility of intraoperative fluorescein guidance, a technique based on the staining of blood-brain barrier breakdown areas with fluorescein. Patients will be identified from the list of patients operated on under fluorescence maintained by the department since the acquisition of the technique. Clinical datas will be collected and surgical videos will be analyzed to assess the presence of intraoperative fluorescence and its subjectively judged intensity (absent, weak, medium, strong). MRI data (quality of excision: total, subtotal or partial according to usual criteria) will be extracted from the radiological reports. No additional data will be produced

Interventions

None listed

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Over 18 years old patient * Fluoroguided removal of a histologically proven Ganglioglioma or Dysembryoplastic Neuroepithelial Tumors between 2015-2018 * Surgical video available

Exclusion criteria

* Absence of surgical video * Adults who are subject to legal protection (protection of justice, guardianship, guardianship) * Patient objecting to the use of their data

Design outcomes

Primary

MeasureTime frameDescription
Number of Intraoperative tumor fluorescence2 monthsNumber of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.

Secondary

MeasureTime frameDescription
Number of allergic events2 monthsNumber of allergic events during fluorescein-based surgery
Percentage of excised tumour volume2 monthsPercentage of excised tumour volume. Quality of excision on the post-operative MRI control according to the volume of the remaining pathological contrast intake (complete, subtotal or partial)
Number of epilepsy events after surgery2 monthsOccurence of postoperative epilepsy events using Engels classification. (Class I: Free of disabling seizures, Class II: Rare disabling seizures (almost seizure-free), Class III: Worthwhile improvement, Class IV: No worthwhile improvement)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026