Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 79 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05470374
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sklifosovsky Institute of Emergency Care
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alexander Dmitriev, MD
Principal Investigator Affiliation Sklifosovsky Institute of Emergency Care
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-enhancing Cerebral Gliomas
Additional Details

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.

Arms & Interventions

Arms

Experimental: Ultrasound

Glioma resection with intraoperative sonography

No Intervention: Non-ultrasound

Glioma resection without intraoperative sonography

Interventions

Procedure: - Intraoperative sonography

ultrasound scanning of brain to search tumor remnants

Contact a Trial Team

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International Sites

Sklifosovsky Institute of Emergency Care, Moscow, Russian Federation

Status

Recruiting

Address

Sklifosovsky Institute of Emergency Care

Moscow, , 129090

Site Contact

Alexander Dmitriev, MD

[email protected]

+7 (916) 423-54-08

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