Patients With Radiological, Clinical and Anamnestic Picture Compatible With a New Diagnosis of Glioblastoma
Conditions
Brief summary
The present study aims to evaluate and compare with the histopathological analysis the various margin-assessment systems, including ultrasound, florescence, brightfield vision, new optical filters and microscope image post-processing systems, for the treatment of High Grade Gliomas (HGGs)
Detailed description
Extent of Resection represents the cornerstone of surgery in terms of improving the prognosis of the patient with High Grade Gliomas, but total removal of neoplastic tissue is prevented by the amount of infiltration that is undetectable either by traditional preoperative MRI techniques or by the naked eye during surgery. Several techniques are currently used to define margins in the surgical setting, but the literature available on them to date is mostly focused on the assessment of postoperative GTR (Gross Total Resection), which tends to underestimate neoplastic tissue infiltration. The evaluation of the efficacy of these techniques in detecting tumour infiltration by comparing them with the histopathology response on intraoperative biopsies taken after the debulking phase of the neoplasm could overcome this sensitivity limitation. The study therefore intends to develop an algorithm that allows to discern between tumour infiltration and healthy parenchyma by means of different margin-assessment techniques in order to maximise the extent of resection in patients with HGGs.
Interventions
OTHERFluid MAX group
to evaluate and compare with the histopathological analysis the various margin-assessment systems, including ultrasound, florescence, brightfield vision, new optical filters and microscope image post-processing systems, for the treatment of High Grade Gliomas (HGGs)
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients with radiological, clinical and anamnestic picture compatible with a new diagnosis of Glioblastoma for whom there is an indication for cytoreductive surgery at the Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.
Exclusion criteria
* Patients aged less than 18 years at the time of radiological diagnosis * Patients who have received radiation therapy in the same area as the neoplasm of interest * Patients contraindicated to 5-ALA administration * Patients whose neoplasm is in close proximity to functionally eloquent areas (Primary Motor, Broca's, Wernicke's areas) * Patients who have not given their consent to take part in the research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | year 2 | Evaluation of Sensitivity and Specificity of individual techniques (bright field observation, 5-ALA FGS and ioUS) in detecting tumor infiltration quantified by histopathological examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | year 2 | Conduct a feasibility study on the use of the above techniques in sequence described; |
Other
| Measure | Time frame | Description |
|---|---|---|
| third Outcome | year 2 | compare the performance of the new Glow400 fluorescence technique with the traditional FL400 in identifying tumor infiltration with respect to the examination histopathology |
| fourth Outcome | year 2 | identify histological and / or genetic characteristics capable of influencing the performance of margin assessment techniques |
Contacts
Primary ContactAlessandro Perin, MD -PhD
Outcome results
None listed