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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | Intraoperative extent of tumor resection will be assessed using sonography |
|
| Fluorescence | Active Comparator | Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided brain tumor resection | Device | Surgeon intraoperatively assesses extent of tumor resection using ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gross total resection (Yes or No) | No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging | within 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of resection (in percents) | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 | within 48 hours after surgery |
| Motor function (in grades) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Dmitriev, MD | Sklifosovsky Institute of Emergency Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sklifosovsky Institute of Emergency Care | Moscow | 129090 | Russia |
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Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
| 5-aminolevulinic acid fluorescence-guided brain tumor resection | Device | Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope |
|
Motor function is assessed in Medical Research Council scale
| within 10 days after surgery |
| Speech function (in grades) | Speech function is assessed in Hendrix scale (2017) | within 10 days after surgery |
| Karnofsky performance status (in percents) | Assesses patients' possibilities to self-service in Karnofsky Performance Status scale | within 10 days after surgery |
| Cerebral complications | Which cerebral complications arose after surgery | From admission to intensive care unit after surgery till hospital discharge, up to 365 days |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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