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RECRUITING Not applicable ClinicalTrials.gov

Concurrent Fluorescence and Sonographically Guided Eradication of High-grade Gliomas and Metastases

Sponsor: Sklifosovsky Institute of Emergency Care • ClinicalTrials.gov ID: NCT05474573

Registry updated: 2026-10-16
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Description

The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.

Interventions

  • Combined ultrasound and fluorescence-guided brain tumor resection (Device)
    Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
  • Fluorescence-guided brain tumor resection (Device)
    Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Eligibility criteria

Inclusion Criteria: * single high-grade glioma * solitary, single or multiple brain metastases of solid tumors of any primary origin * newly diagnosed * Karnofsky Performance Status 60-100% * age 18-80 years * performed magnetic resonance imaging with contrast enhancement * intraoperative use of 5-aminolevulinic acid induced fluorescence. Exclusion Criteria: * tumor spreading to corpus callosum or brainstem * history of brain tumor 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

Conditions

Glioma, Malignant Metastases to Brain

Locations

  • Sklifosovsky Institute of Emergency Care — Moscow, Russia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record