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出境医 / 临床实验 / Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors (FLUOGOD)

Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors (FLUOGOD)

Study Description
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

Condition or disease
Surgical Procedure, Unspecified

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 Design
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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors
Actual Study Start Date : July 15, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : May 15, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Number of Intraoperative tumor fluorescence [ Time Frame: 2 months ]
    Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.


Secondary Outcome Measures :
  1. Number of allergic events [ Time Frame: 2 months ]
    Number of allergic events during fluorescein-based surgery

  2. Percentage of excised tumour volume [ Time Frame: 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)

  3. Number of epilepsy events after surgery [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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
Contacts and Locations

Locations
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France
CHU Rennes
Rennes, France
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Pierre-Jean LE RESTE, Md Rennes University Hospital
Tracking Information
First Submitted Date May 29, 2019
First Posted Date June 3, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date July 15, 2018
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2019)
Number of Intraoperative tumor fluorescence [ Time Frame: 2 months ]
Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 29, 2019)
  • Number of allergic events [ Time Frame: 2 months ]
    Number of allergic events during fluorescein-based surgery
  • Percentage of excised tumour volume [ Time Frame: 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 [ Time Frame: 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors
Official Title Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Surgical Procedure, Unspecified
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 29, 2019)
7
Original Actual Enrollment Same as current
Actual Study Completion Date May 15, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03970785
Other Study ID Numbers 35RC18_3046_FLUOGOD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Rennes University Hospital
Study Sponsor Rennes University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Pierre-Jean LE RESTE, Md Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date May 2019