Glioma, 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 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.
Detailed description
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.
Interventions
DEVICECombined ultrasound and fluorescence-guided brain tumor resection
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
DEVICEFluorescence-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 from any cancer * 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
Contacts
Primary ContactAlexander Dmitriev, MD
Outcome results
None listed