Non-enhancing Cerebral Gliomas
Conditions
Brief summary
The purpose of the study is to determine whether intraoperative ultrasound guided resection of glioma without contrast enhancement in magnetic resonance imaging can achieve higher extent of resection than surgery without intraoperative sonography
Detailed description
Gliomas, not enhancing contrast agent in magnetic resonance imaging (MRI), are usually low-grade gliomas. They rarely show intraoperative fluorescence using 5-aminolevulinic acid or fluorescein. Intraoperative high-field MRI, sonography and navigation are the only ways to assess extent of their resection during surgery. MRI is the gold standard, but interrupts surgical workflow and only few hospitals are equipped with device like that. Navigation eventually looses it's precision due to brainshift. Ultrasound allows assess tumor remnants in real time but has worse imaging quality. Currently no randomized trials published their results about efficiency of intraoperative sonography in removing low-grade gliomas. Objective of the study is to determine whether intraoperative ultrasound guided resection of non-enhancing gliomas can achieve higher extent of resection than surgery without intraoperative sonography. Participants of the study will be randomly operated with and without intraoperative ultrasound. Extent of resection will be assessed in postoperative MRI by blinded radiologists.
Interventions
PROCEDUREIntraoperative sonography
ultrasound scanning of brain to search tumor remnants
Sponsors
Sklifosovsky Institute of Emergency Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Glioma 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 supratentorial gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas) * newly diagnosed * previously untreated * Karnofsky Performance Status 60-100% * age 18-79 years * performed magnetic resonance imaging with contrast enhancement
Exclusion criteria
* glioma spreading to brainstem * previously performed radiotherapy, chemotherapy or immunotherapy * planned supratotal tumor resection until neurophysiologically revealed eloquent areas
Design outcomes
Primary
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gross total resection (Yes or No) | within 48 hours after surgery | Gross total resection is a total removal of tumor (or 100 percents extent of resection) |
| 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 |
| 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