Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases
Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Sklifosovsky Institute of Emergency Care
52 participants
Sep 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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
Interventions
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
Locations(1)
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NCT05474573