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

Sklifosovsky Institute of Emergency Care134 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

134

Conditions

Gliomas, Malignant Metastases to Brain

Interventions

Ultrasound guided brain tumor resectionDEVICE

Surgeon intraoperatively assesses extent of tumor resection using ultrasound

5-aminolevulinic acid fluorescence-guided brain tumor resectionDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Sklifosovsky Institute of Emergency Care

Moscow, Russia

Outcomes

Primary Outcomes

Gross total resection (Yes or No)

No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging

Time frame: within 48 hours after surgery

Secondary Outcomes

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

Data from ClinicalTrials.gov

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