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.
Fluorescence-guided resection of contrast-enhancing gliomas and metastases increases extent of tumor resection. But the main drawback of this method is an inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing to reveal such tumor remnants. By the time there are published results of randomized control trials comparing these two technics. 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. Participants of the study will be randomly operated using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. Extent of resection will be assessed in postoperative MRI by blinded radiologists.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
Sklifosovsky Institute of Emergency Care
Moscow, Russia
RECRUITINGGross total resection (Yes or No)
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
Time frame: within 48 hours after surgery
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time frame: within 48 hours after surgery
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Time frame: within 10 days after surgery
Speech function (in grades)
Speech function is assessed in Hendrix scale (2017)
Time frame: within 10 days after surgery
Karnofsky performance status (in percents)
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Time frame: within 10 days after surgery
Cerebral complications
Which cerebral complications arose after surgery
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
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