Gliomas, Malignant, Metastases to Brain
Conditions
Keywords
contrast-enhancing glioma, brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA
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
Interventions
DEVICEUltrasound guided brain tumor resection
Surgeon intraoperatively assesses extent of tumor resection using ultrasound
DEVICE5-aminolevulinic acid fluorescence-guided brain tumor resection
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
Sponsors
Sklifosovsky Institute of Emergency Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross total resection (Yes or No) | within 48 hours after surgery | No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extent of resection (in percents) | within 48 hours after surgery | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 |
| 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 |
| Cerebral complications | From admission to intensive care unit after surgery till hospital discharge, up to 365 days | Which cerebral complications arose after surgery |
Countries
Russia
Outcome results
None listed