NCT05475522

Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases

Intraoperative Sonographically Guided Versus 5-Aminolevulinic Acid Fluorescence Guided Resection of Gliomas and Brain Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled, Noninferiority Trial

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Sklifosovsky Institute of Emergency Care · Other Government
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid

Detailed description

Fluorescence with 5-aminolevulinic acid, fluorescein and intraoperative magnetic resonance imaging (MRI) are the most common modalities used to intraoperatively rate extent of brain tumor resection. Intraoperative sonography is another promising method of intraoperative visualization. It's advantages include possibility of real-time estimation of tumor remnants without disturbing of surgical workflow, opportunity to discover residual tumor under normal brain tissue and chipper cost. At this time there are no published results of randomized control trials comparing ultrasound and fluorescence-guided brain tumor resection. Objective of this study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as 5-aminolevulinic acid fluorescence-guided surgery. Participants of the study will be randomly operated using intraoperative ultrasound or fluorescence with 5-aminolevulinic acid. Extent of resection will be assessed in postoperative MRI by blinded radiologists

Conditions

• Gliomas, Malignant
• Metastases to Brain

Interventions

Type	Name	Description
DEVICE	Ultrasound guided brain tumor resection	Surgeon intraoperatively assesses extent of tumor resection using ultrasound
DEVICE	5-aminolevulinic acid fluorescence-guided brain tumor resection	Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Timeline

• Start date: 2022-09-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2022-07-27
• Last updated: 2025-05-16

Locations

1 site across 1 country: Russia