Surgical Procedure, Unspecified Clinical Trial
— FLUOGODOfficial title:
Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors
Verified date | May 2019 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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 |
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