Clinical trial NCT05475522: Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases
Official title: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Gliomas, Malignant
Metastases to Brain
Keywords: contrast-enhancing glioma
brain metastasis
sonography
ultrasound
fluorescence
5-aminolevulinic acid
5-ALA
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2022-07-27
Enrollment: 134
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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Gross total resection (Yes or No)
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Extent of resection (in percents)
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: