Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors

NCT03970785 | Completed

• 1 other identifier: 35RC18_3046_FLUOGOD
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Procedure, Unspecified

Keywords

fluorescein; gangliogliomas; glioneuronal; Dysembryoplastic Neuroepithelial Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Intraoperative tumor fluorescence

  Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.

  2 months

Secondary Outcomes (3)

• Number of allergic events

  2 months

• Percentage of excised tumour volume

  2 months

• Number of epilepsy events after surgery

  2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Over 18 years old patient
• Fluoroguided removal of a histologically proven Ganglioglioma or Dysembryoplastic Neuroepithelial Tumors between 2015-2018
• Surgical video available

You may not qualify if:

• Absence of surgical video
• Adults who are subject to legal protection (protection of justice, guardianship, guardianship)
• Patient objecting to the use of their data

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Ganglioglioma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Pierre-Jean LE RESTE, Md

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: July 15, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 15, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-05

Locations

FR (1)