About this trial
Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
one or several brain metastases from any cancer
newly diagnosed
Karnofsky Performance Status 60-100%
Disqualifiers
tumor spreading to 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
Trial design
Parallel
Treatments tested in this trial
Combined ultrasound and fluorescence-guided brain tumor resection
DeviceSurgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
Fluorescence-guided brain tumor resection
DeviceSurgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
Treatment groups
Trial outcomes
Primary outcomes
Gross total resection (Yes or No)
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
Secondary outcomes
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Speech function (in grades)
Speech function is assessed in Hendrix scale (2017)
Karnofsky performance status (in percents)
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Sponsors and contacts
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