Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors

Surgical Procedure, Unspecified Clinical Trial

— FLUOGOD  

Official title:

Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970785
• Other study ID #: 35RC18_3046_FLUOGOD
• Status: Completed
• Start date: July 15, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 15, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ganglioglioma
• Surgical Procedure, Unspecified

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Intraoperative tumor fluorescence	Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.	2 months
Secondary	Number of allergic events	Number of allergic events during fluorescein-based surgery	2 months
Secondary	Percentage of excised tumour volume	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)	2 months
Secondary	Number of epilepsy events after surgery	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)	2 months