Surgical Procedure, UnspecifiedFLUOGODNCT03970785
Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors
An observational study of Surgical Procedure, Unspecified, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2018to 15 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Over 18 years old patient
- Fluoroguided removal of a histologically proven Ganglioglioma or Dysembryoplastic Neuroepithelial Tumors between 2015-2018
- Surgical video available
Who cannot join
- Absence of surgical video
- Adults who are subject to legal protection (protection of justice, guardianship, guardianship)
- Patient objecting to the use of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors
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
Read the 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
- Surgical Procedure, Unspecified
- Keywords
- fluorescein, gangliogliomas, glioneuronal, Dysembryoplastic Neuroepithelial Tumor
- Medical subject headings
- Ganglioglioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Intraoperative tumor fluorescence
Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.
Measured: 2 months
Secondary outcomes (3)
Number of allergic events
Number of allergic events during fluorescein-based surgery
Measured: 2 months
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)
Measured: 2 months
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start15 Jul 2018
- Primary completion30 Apr 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Jean LE RESTE, Md, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970785
- Sponsor's protocol ID
- 35RC18_3046_FLUOGOD
- Acronym
- FLUOGOD
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors
- ClinicalTrials.gov ID
- NCT03970785
- Acronym / sponsor ID
- FLUOGOD / 35RC18_3046_FLUOGOD
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- fluorescein, gangliogliomas, glioneuronal, Dysembryoplastic Neuroepithelial Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Over 18 years old patient
- Fluoroguided removal of a histologically proven Ganglioglioma or Dysembryoplastic Neuroepithelial Tumors between 2015-2018
- Surgical video available
Key exclusion criteria (3 listed)
- Absence of surgical video
- Adults who are subject to legal protection (protection of justice, guardianship, guardianship)
- Patient objecting to the use of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Intraoperative tumor fluorescence
Time frame: 2 months
Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.
3 secondary outcomes
Number of allergic events
Time frame: 2 months
Percentage of excised tumour volume
Time frame: 2 months
Number of epilepsy events after surgery
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Jean LE RESTE, Md principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Intraoperative tumor fluorescence (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.