Glioblastoma Clinical Trial
Official title:
Randomized, Prospective, Multicenter Blinding Singles With Arm A and Arm B Innovative Strategy Strategy Conventional
Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases
per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is
based mainly on surgical excision as complete as possible followed by an additional
radiochemotherapy. The prognosis depends mainly on the quality of resection when it is
macroscopically complete. Different techniques to support the surgical resection have been
developed over the past 20 years. The reference technique is currently the intraoperative
neuronavigation for guiding excision by matching the intraoperative tumor boundaries with
those of the preoperative MRI. Its main drawback is the loss of precision during the
resection related to changes in anatomical limits of the tumor.
The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique
to support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by
the patient before surgery is captured specifically by the tumor cells and transformed into
a fluorochrome revealed intraoperatively by a light source length adapted wave with a set of
lenses included in the microscope. Resection is thus guided by this fluorescence whose
disappearance translates complete tumor resection.
Its interest is twofold:
- Increase the percentage of complete tumor resection.
- Improve disease-free survival and overall survival. The objective of the study is to
compare the FGS to the intraoperative neuronavigation for the resection of
glioblastoma, on a medical and economical level through a randomized, prospective,
multicenter trial.
The annual number of patients likely to benefit of this technique in France is estimated at
2200 new cases.
Main Outcome Measure: Percentage of patients with surgical resection of the tumor is complete, objectified by the absence of residual tumor on MRI early postoperative (within 48 hours) by a central committee of independent reading with qualitative analysis taking a contrast replay console for diagnostic use ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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