Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases (CONFLUENSE)

Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial

Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.

Study Overview

• Status: Recruiting
• Conditions: Glioma, Malignant; Metastases to Brain
• Intervention / Treatment: Device: Combined ultrasound and fluorescence-guided brain tumor resection; Device: Fluorescence-guided brain tumor resection

Detailed Description

Fluorescence-guided resection of contrast-enhancing gliomas and metastases increases extent of tumor resection. But the main drawback of this method is an inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing to reveal such tumor remnants. By the time there are published results of randomized control trials comparing these two technics.

Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.

Participants of the study will be randomly operated using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. Extent of resection will be assessed in postoperative MRI by blinded radiologists.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Dmitriev, MD; Phone Number: +7 (916) 423-54-08; Email: dmitriev@neurosklif.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129090
    • Recruiting
    • Sklifosovsky Institute of Emergency Care
    • Contact: Alexander Dmitriev, MD; Phone Number: +7 (916) 423-54-08; Email: dmitriev@neurosklif.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 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 from any cancer
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluorescence and Ultrasound; Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography	Device: Combined ultrasound and fluorescence-guided brain tumor resection; Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
Active Comparator: Fluorescence; Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid	Device: 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)	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)	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100	within 48 hours after surgery
Motor function (in grades)	Motor function is assessed in Medical Research Council scale	within 10 days after surgery
Speech function (in grades)	Speech function is assessed in Hendrix scale (2017)	within 10 days after surgery
Karnofsky performance status (in percents)	Assesses patients' possibilities to self-service in Karnofsky Performance Status scale	within 10 days after surgery
Cerebral complications	Which cerebral complications arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days

Collaborators and Investigators

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

Study record dates

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 23, 2022
• First Submitted That Met QC Criteria: July 23, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; 5-ALA; brain metastasis; sonography; fluorescence; 5-aminolevulinic acid; contrast-enhancing glioma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasm Metastasis; Glioma
• Other Study ID Numbers: 9c

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
• product manufactured in and exported from the U.S.: No