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Search / Trial NCT05474573

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

Launched by SKLIFOSOVSKY INSTITUTE OF EMERGENCY CARE · Jul 23, 2022

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Contrast Enhancing Glioma Brain Metastasis Sonography Ultrasound Fluorescence 5 Aminolevulinic Acid 5 Ala

ClinConnect Summary

This clinical trial is looking at a new method to help doctors remove brain tumors called gliomas and brain metastases, which are tumors that have spread to the brain from other parts of the body. The study aims to find out if using a special dye called 5-aminolevulinic acid (5-ALA) combined with ultrasound imaging during surgery can help doctors remove more of the tumor compared to using the dye alone. This could potentially lead to better outcomes for patients by ensuring that more of the cancerous tissue is removed during surgery.

To be eligible for this trial, participants should be between 18 and 79 years old and have a single glioma that shows up as enhanced on a brain scan, or have one or more brain metastases. They should also be newly diagnosed and have a certain level of health status, meaning they can perform daily activities with some assistance if needed. However, individuals with specific conditions or who have had previous brain treatments may not qualify. If you participate, you can expect to undergo surgery with the new imaging method, and your progress will be closely monitored throughout the study.

Gender

ALL

Eligibility criteria

  • 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

About Sklifosovsky Institute Of Emergency Care

The Sklifosovsky Institute of Emergency Care is a leading clinical research organization dedicated to advancing emergency medicine through innovative research and development. Renowned for its expertise in urgent medical interventions, the institute conducts rigorous clinical trials aimed at improving patient outcomes and enhancing treatment protocols. With a multidisciplinary team of experienced healthcare professionals, researchers, and clinicians, the Sklifosovsky Institute is committed to fostering collaboration and utilizing cutting-edge methodologies to address critical healthcare challenges in emergency settings. Its focus on evidence-based practices ensures that findings contribute significantly to the global body of knowledge in emergency care.

Locations

Moscow, , Russian Federation

Patients applied

0 patients applied

Trial Officials

Alexander Dmitriev, MD

Principal Investigator

Sklifosovsky Institute of Emergency Care

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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