Clinical trial NCT03970785: Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors
Official title: Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Keywords: fluorescein
gangliogliomas
glioneuronal
Dysembryoplastic Neuroepithelial Tumor
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seven patients (5 men, 2 women, mean age 30 year-old) underwent fluorescein-guided resection of gangliogliomas (5/7; 4 WHO Grade I, 1 WHO Grade III) and DNT (2/7).

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Intraoperative tumor fluorescence
timeFrame: 2 months
Secondary outcomes:
measure: Number of allergic events
timeFrame: 2 months
measure: Percentage of excised tumour volume
timeFrame: 2 months
measure: Number of epilepsy events after surgery
timeFrame: 2 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Rennes University Hospital
name: Pierre-Jean LE RESTE, Md
role: PRINCIPAL_INVESTIGATOR
References: