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

Sponsor

Sklifosovsky Institute of Emergency Care (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05475522

Collaborator

(none)

134

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gliomas, Malignant Metastases to Brain	Device: Ultrasound guided brain tumor resection Device: 5-aminolevulinic acid fluorescence-guided brain tumor resection	N/A

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

Anticipated Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Tumor extent of resection will be assessed by radiologists blinded for the treatment arm

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound Intraoperative extent of tumor resection will be assessed using sonography	Device: Ultrasound guided brain tumor resection Surgeon intraoperatively assesses extent of tumor resection using ultrasound
Active Comparator: Fluorescence Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid	Device: 5-aminolevulinic acid fluorescence-guided brain tumor resection Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Arm

Intervention/Treatment

Experimental: Ultrasound

Intraoperative extent of tumor resection will be assessed using sonography

Device: Ultrasound guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection using ultrasound

Active Comparator: Fluorescence

Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid

Device: 5-aminolevulinic acid fluorescence-guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Outcome Measures

Primary Outcome Measures

Gross total resection (Yes or No) [within 48 hours after surgery]
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging

Secondary Outcome Measures

Extent of resection (in percents) [within 48 hours after surgery]
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Dynamics of neurological status before and after surgery [within 10 days after surgery]
Motor function is measured in Medical Research Council scale, speech function - in Bilingual Aphasia Screening Test (Russian version), visual function - in measuring of visual fields in perimetry, cognitive disturbances - in Montreal Cognitive Assessment scale
Karnofsky performance status (in percents) [within 10 days after surgery]
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 basal ganglia, 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