Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases (SONOFLUO)

Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases

Intraoperative Sonographically Guided Versus 5-Aminolevulinic Acid Fluorescence Guided Resection of Gliomas and Brain Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled, Noninferiority Trial

Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid

Fluorescence with 5-aminolevulinic acid, fluorescein and intraoperative magnetic resonance imaging (MRI) are the most common modalities used to intraoperatively rate extent of brain tumor resection. Intraoperative sonography is another promising method of intraoperative visualization. It's advantages include possibility of real-time estimation of tumor remnants without disturbing of surgical workflow, opportunity to discover residual tumor under normal brain tissue and chipper cost. At this time there are no published results of randomized control trials comparing ultrasound and fluorescence-guided brain tumor resection. Objective of this study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as 5-aminolevulinic acid fluorescence-guided surgery. Participants of the study will be randomly operated using intraoperative ultrasound or fluorescence with 5-aminolevulinic acid. Extent of resection will be assessed in postoperative MRI by blinded radiologists

contrast-enhancing glioma, brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA

Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid

Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Inclusion Criteria: single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas) one or several brain metastases newly diagnosed Karnofsky Performance Status 60-100% age 18-79 years performed magnetic resonance imaging with contrast enhancement Exclusion Criteria: tumor spreading to basal ganglia, corpus callosum or brainstem previously performed brain radiotherapy planned supratotal tumor resection until neurophysiologically revealed eloquent areas known hypersensibility to 5-aminolevulinic or to porphyrin hepatic or renal insufficiency porphyria pregnancy breast feeding