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Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas
SONOGLIO
1 other identifier
interventional
96
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
May 16, 2025
May 1, 2025
5 years
July 19, 2022
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Extent of resection in percents
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
within 48 hours after surgery
Secondary Outcomes (5)
Gross total resection (Yes or No)
within 48 hours after surgery
Motor function (in grades)
within 10 days after surgery
Speech function (in grades)
within 10 days after surgery
Karnofsky Performance status in percents
within 10 days after surgery
Cerebral complications
From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Study Arms (2)
Ultrasound
EXPERIMENTALGlioma resection with intraoperative sonography
Non-ultrasound
NO INTERVENTIONGlioma resection without intraoperative sonography
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- glioma spreading to brainstem
- previously performed radiotherapy, chemotherapy or immunotherapy
- planned supratotal tumor resection until neurophysiologically revealed eloquent areas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sklifosovsky Institute of Emergency Care
Moscow, 129090, Russia
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Dmitriev, MD
Sklifosovsky Institute of Emergency Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Glioma extent of resection will be assessed by radiologists blinded for the treatment arm
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurosurgeon, MD
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 22, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share