Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors

Completed

• Conditions: Surgical Procedure, Unspecified

• Registration Number: NCT03970785
• Lead Sponsor: Rennes University Hospital

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

Study Timeline

• Study Start: 2018-07-15
• Primary Completion: 2019-04-30
• Status Verified: 2019-05
• Study Completion: 2019-05-15
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Last Update Submitted: 2019-05-31
• Study First Posted: 2019-06-03
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Intraoperative tumor fluorescence	2 months	Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.

Secondary Outcome Measures

Name	Time	Method
Number of allergic events	2 months	Number of allergic events during fluorescein-based surgery
Percentage of excised tumour volume	2 months	Percentage 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 surgery	2 months	Occurence 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)

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France