Randomized, Prospective, Multicenter Blinding Singles With Arm A and Arm B Innovative Strategy Strategy Conventional
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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Comparison of complete tumor resection between the 2 arms
Evidenced of complete resection (absence of residual tumor on early postoperative MRI (within 48 hours)) will be assessed by a central independent committee with qualitative analysis of contrast enhancement replay on a console for diagnostic use.
48 hours
No
Jacques GUYOTAT, MD
Study Director
Hospices Civils de Lyon
France: Agence Nationale de Sécurité du Médicament et des produits de santé
2011-697
NCT01811121
February 2013
August 2019
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