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
Overview
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Sklifosovsky Institute of Emergency Care
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Gross total resection (Yes or No)
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
- •one or several brain metastases
- •newly diagnosed
- •Karnofsky Performance Status 60-100%
- •age 18-79 years
- •performed magnetic resonance imaging with contrast enhancement
Exclusion Criteria
- •tumor spreading to corpus callosum or brainstem
- •previously performed brain radiotherapy
- •planned supratotal tumor resection until neurophysiologically revealed eloquent areas
- •known hypersensibility to 5-aminolevulinic or to porphyrin
- •hepatic or renal insufficiency
- •porphyria
- •pregnancy
- •breast feeding
Outcomes
Primary Outcomes
Gross total resection (Yes or No)
Time Frame: within 48 hours after surgery
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
Secondary Outcomes
- Motor function (in grades)(within 10 days after surgery)
- Speech function (in grades)(within 10 days after surgery)
- Karnofsky performance status (in percents)(within 10 days after surgery)
- Cerebral complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)
- Extent of resection (in percents)(within 48 hours after surgery)
Investigators
Alexander Dmitriev
Principal Investigator
Sklifosovsky Institute of Emergency Care