Clinical Trials Directory

Trials / Completed

CompletedNCT03970785

Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors

Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors

Status
Completed
Phase
Study type
Observational
Enrollment
7 (actual)
Sponsor
Rennes University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2018-07-15
Primary completion
2019-04-30
Completion
2019-05-15
First posted
2019-06-03
Last updated
2019-06-04

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03970785. Inclusion in this directory is not an endorsement.