Clinical trial NCT05470374: Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas
Official title: Intraoperative Sonographically Guided Resection of Gliomas Not Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Non-enhancing Cerebral Gliomas
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2022-07-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 brainstem
* previously performed radiotherapy, chemotherapy or immunotherapy
* planned supratotal tumor resection until neurophysiologically revealed eloquent areas

Primary outcomes:
measure: Extent of resection in percents
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Gross total resection (Yes or No)
timeFrame: within 48 hours after surgery
measure: Motor function (in grades)
timeFrame: within 10 days after surgery
measure: Speech function (in grades)
timeFrame: within 10 days after surgery
measure: Karnofsky Performance status in percents
timeFrame: within 10 days after surgery
measure: Cerebral complications
timeFrame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sklifosovsky Institute of Emergency Care
Study officials:
affiliation: Sklifosovsky Institute of Emergency Care
name: Alexander Dmitriev, MD
role: PRINCIPAL_INVESTIGATOR
References: