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

Not Applicable

Recruiting

• Conditions: Metastases to Brain; Glioma, Malignant
• Interventions: Device: Combined ultrasound and fluorescence-guided brain tumor resection; Device: Fluorescence-guided brain tumor resection

• Registration Number: NCT05474573
• Lead Sponsor: Sklifosovsky Institute of Emergency Care

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-23
• Study First Submitted QC: 2022-07-23
• Study First Posted: 2022-07-26
• Study Start: 2022-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluorescence and Ultrasound	Combined ultrasound and fluorescence-guided brain tumor resection	Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography
Fluorescence	Fluorescence-guided brain tumor resection	Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Sklifosovsky Institute of Emergency Care; 🇷🇺 Moscow, Russian Federation