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

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

Recruiting
18-79 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Glioma
    Malignant
    Metastases to Brain

NCT05474573

Sklifosovsky Institute of Emergency Care

23 May 2025

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