Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases
- Conditions
- Gliomas, MalignantMetastases to Brain
- Interventions
- Device: 5-aminolevulinic acid fluorescence-guided brain tumor resectionDevice: Ultrasound guided brain tumor resection
- Registration Number
- NCT05475522
- Lead Sponsor
- Sklifosovsky Institute of Emergency Care
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 134
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluorescence 5-aminolevulinic acid fluorescence-guided brain tumor resection Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid Ultrasound Ultrasound guided brain tumor resection Intraoperative extent of tumor resection will be assessed using sonography
- Primary Outcome Measures
Name Time Method Gross total resection (Yes or No) within 48 hours after surgery No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
- Secondary Outcome Measures
Name Time Method Motor function (in grades) within 10 days after surgery Motor function is assessed in Medical Research Council scale
Speech function (in grades) within 10 days after surgery Speech function is assessed in Hendrix scale (2017)
Karnofsky performance status (in percents) within 10 days after surgery Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Extent of resection (in percents) within 48 hours after surgery Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Cerebral complications From admission to intensive care unit after surgery till hospital discharge, up to 365 days Which cerebral complications arose after surgery
Trial Locations
- Locations (1)
Sklifosovsky Institute of Emergency Care
🇷🇺Moscow, Russian Federation