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

April 5, 2024 updated by: Alexander Dmitriev, Sklifosovsky Institute of Emergency Care

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 129090
        • Recruiting
        • Sklifosovsky Institute of Emergency Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross total resection (Yes or No)
Time Frame: within 48 hours after surgery
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
within 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of resection (in percents)
Time Frame: within 48 hours after surgery
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
within 48 hours after surgery
Motor function (in grades)
Time Frame: within 10 days after surgery
Motor function is assessed in Medical Research Council scale
within 10 days after surgery
Speech function (in grades)
Time Frame: within 10 days after surgery
Speech function is assessed in Hendrix scale (2017)
within 10 days after surgery
Karnofsky performance status (in percents)
Time Frame: within 10 days after surgery
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
within 10 days after surgery
Cerebral complications
Time Frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Which cerebral complications arose after surgery
From admission to intensive care unit after surgery till hospital discharge, up to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sklifosovsky Institute of Emergency Care

Investigators

  • Principal Investigator: Alexander Dmitriev, MD, Sklifosovsky Institute of Emergency Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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