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

NCT05475522 | Suspended

• 1 other identifier: 9b
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Conditions

Gliomas, Malignant; Metastases to Brain

Keywords

contrast-enhancing glioma; brain metastasis; sonography; ultrasound; fluorescence; 5-aminolevulinic acid; 5-ALA

Outcome Measures

Primary Outcomes (1)

• Gross total resection (Yes or No)

  No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging

  within 48 hours after surgery

Secondary Outcomes (5)

• Extent of resection (in percents)

  within 48 hours after surgery

• 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

Study Arms (2)

Ultrasound

EXPERIMENTAL

Intraoperative extent of tumor resection will be assessed using sonography

Device: Ultrasound guided brain tumor resection

Fluorescence

ACTIVE COMPARATOR

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

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

Interventions

Ultrasound guided brain tumor resection DEVICE

Surgeon intraoperatively assesses extent of tumor resection using ultrasound

Ultrasound

5-aminolevulinic acid fluorescence-guided brain tumor resection DEVICE

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

Fluorescence

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead

Study Sites (1)

Sklifosovsky Institute of Emergency Care

Moscow, 129090, Russia

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alexander Dmitriev, MD

  Sklifosovsky Institute of Emergency Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 27, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)