SONOGLIO: Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ultrasound Glioma resection with intraoperative sonography |
Procedure: Intraoperative sonography
ultrasound scanning of brain to search tumor remnants
|
| No Intervention: Non-ultrasound Glioma resection without intraoperative sonography |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- Neurological deterioration after surgery (improving, stable, deterioration) [within 10 days after surgery]
Assesses dynamics of motor, speech, visual and cognitive functions before and after surgery
- Karnofsky Performance status in percents [within 10 days after surgery]
Assesses patients' possibilities to self-service
Eligibility Criteria
Criteria
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 basal ganglia or brainstem
-
previously performed radiotherapy, chemotherapy or immunotherapy
-
planned supratotal tumor resection until neurophysiologically revealed eloquent areas
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sklifosovsky Institute of Emergency Care | Moscow | Russian Federation | 129090 |
Sponsors and Collaborators
- Sklifosovsky Institute of Emergency Care
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9