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Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas (SONOGLIO)

Primary Purpose

Non-enhancing Cerebral Gliomas

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Intraoperative sonography
Sponsored by
Sklifosovsky Institute of Emergency Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-enhancing Cerebral Gliomas

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sklifosovsky Institute of Emergency CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ultrasound

Non-ultrasound

Arm Description

Glioma resection with intraoperative sonography

Glioma resection without intraoperative sonography

Outcomes

Primary Outcome Measures

Extent of resection in percents
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Secondary Outcome Measures

Gross total resection (Yes or No)
Gross total resection is a total removal of tumor (or 100 percents extent of resection)
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Speech function (in grades)
Speech function is assessed in Hendrix scale (2017)
Karnofsky Performance status in percents
Assesses patients' possibilities to self-service
Cerebral complications
Which cerebral complications arose after surgery

Full Information

First Posted
July 19, 2022
Last Updated
December 12, 2022
Sponsor
Sklifosovsky Institute of Emergency Care
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1. Study Identification

Unique Protocol Identification Number
NCT05470374
Brief Title
Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas
Acronym
SONOGLIO
Official Title
Intraoperative Sonographically Guided Resection of Gliomas Not Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sklifosovsky Institute of Emergency Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-enhancing Cerebral Gliomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Glioma extent of resection will be assessed by radiologists blinded for the treatment arm
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Glioma resection with intraoperative sonography
Arm Title
Non-ultrasound
Arm Type
No Intervention
Arm Description
Glioma resection without intraoperative sonography
Intervention Type
Procedure
Intervention Name(s)
Intraoperative sonography
Intervention Description
ultrasound scanning of brain to search tumor remnants
Primary Outcome Measure Information:
Title
Extent of resection in percents
Description
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time Frame
within 48 hours after surgery
Secondary Outcome Measure Information:
Title
Gross total resection (Yes or No)
Description
Gross total resection is a total removal of tumor (or 100 percents extent of resection)
Time Frame
within 48 hours after surgery
Title
Motor function (in grades)
Description
Motor function is assessed in Medical Research Council scale
Time Frame
within 10 days after surgery
Title
Speech function (in grades)
Description
Speech function is assessed in Hendrix scale (2017)
Time Frame
within 10 days after surgery
Title
Karnofsky Performance status in percents
Description
Assesses patients' possibilities to self-service
Time Frame
within 10 days after surgery
Title
Cerebral complications
Description
Which cerebral complications arose after surgery
Time Frame
From admission to intensive care unit after surgery till hospital discharge, up to 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Organizational Affiliation
Sklifosovsky Institute of Emergency Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sklifosovsky Institute of Emergency Care
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas

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