RecruitingNot ApplicableNCT05474573

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


Sponsor

Sklifosovsky Institute of Emergency Care

Enrollment

52 participants

Start Date

Sep 1, 2022

Study Type

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

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combined approach to brain tumor surgery that uses both fluorescence imaging (a special dye that makes tumor cells glow pink) and ultrasound guidance at the same time, to help surgeons remove more of the tumor while protecting healthy brain tissue. **You may be eligible if...** - You have been newly diagnosed with a single brain tumor that shows contrast enhancement on MRI (suspected high-grade glioma) - You have one or more brain metastases (cancer that has spread to the brain from elsewhere) - You are 18–79 years old and in reasonably good overall health (Karnofsky score 60–100%) **You may NOT be eligible if...** - Your tumor extends into the corpus callosum (bridge between brain halves) or brainstem - You have had previous brain radiation therapy - You have a known allergy to 5-aminolevulinic acid (the fluorescent dye) - You have liver or kidney insufficiency, porphyria, or are pregnant/breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECombined ultrasound and fluorescence-guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography

DEVICEFluorescence-guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope


Locations(1)

Sklifosovsky Institute of Emergency Care

Moscow, Russia

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NCT05474573


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