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

Metastases to Brain Clinical Trial

— SONOFLUO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475522
• Other study ID #: 9b
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: Sklifosovsky Institute of Emergency Care
• Contact: Alexander Dmitriev, MD
• Phone: +7 (916) 423-54-08
• Email: dmitriev[@]neurosklif.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma
• Gliomas, Malignant
• Metastases to Brain
• Neoplasm Metastasis

Intervention

Device:
• Ultrasound guided brain tumor resection
Surgeon intraoperatively assesses extent of tumor resection using ultrasound
• 5-aminolevulinic acid fluorescence-guided brain tumor resection
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Locations

Country	Name	City	State
Russian Federation	Sklifosovsky Institute of Emergency Care	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sklifosovsky Institute of Emergency Care

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross total resection (Yes or No)	No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging	within 48 hours after surgery
Secondary	Extent of resection (in percents)	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100	within 48 hours after surgery
Secondary	Motor function (in grades)	Motor function is assessed in Medical Research Council scale	within 10 days after surgery
Secondary	Speech function (in grades)	Speech function is assessed in Hendrix scale (2017)	within 10 days after surgery
Secondary	Karnofsky performance status (in percents)	Assesses patients' possibilities to self-service in Karnofsky Performance Status scale	within 10 days after surgery
Secondary	Cerebral complications	Which cerebral complications arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days