An interventional study of Combined ultrasound and fluorescence-guided brain tumor resection and Fluorescence-guided brain tumor resection in Glioma, Malignant and Metastases to Brain, sponsored by Sklifosovsky Institute of Emergency Care. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Sklifosovsky Institute of Emergency Care · Not applicable, Interventional, and Treatment
The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Fluorescence-guided resection of high-grade gliomas and brain metastases increases the extent of tumor resection. However, the main drawback of this method is the inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing for the detection of such tumor remnants. To date, there are no published results of randomized controlled trials comparing these two techniques.
The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Participants in the study will be randomly assigned to undergo surgery using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. The extent of resection will be assessed via postoperative MRI by blinded radiologists and neurosurgeons independently.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
This study's planned enrollment of 52 is above the median of 32 across 1,075 interventional studies indexed under Glioma.
Browse Glioma studies →Sklifosovsky Institute of Emergency Care is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography
Device: Combined ultrasound and fluorescence-guided brain tumor resection
Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid
Device: Fluorescence-guided brain tumor resection
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
Gross total resection (Yes or No)
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
Time frame: within 48 hours after surgery
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time frame: within 48 hours after surgery
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Time frame: within 10 days after surgery
Speech function (in grades)
Speech function is assessed in Hendrix scale (2017)
Time frame: within 10 days after surgery
Karnofsky performance status (in percents)
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Time frame: within 10 days after surgery
Cerebral complications
Which cerebral complications arose after surgery
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sklifosovsky Institute of Emergency Care