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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence and Ultrasound | Experimental | Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography |
|
| Fluorescence | Active Comparator | Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined ultrasound and fluorescence-guided brain tumor resection | Device | Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography |
| 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Dmitriev, MD | Contact | +7 (916) 423-54-08 | dmitriev@neurosklif.ru |
| 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 | Recruiting | Moscow | 129090 | Russia |
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Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
| 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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