Using ultrasound and fluorescence to improve brain tumor removal
Official title: Concurrent Fluorescence and Sonographically Guided Eradication of High-grade Gliomas and Metastases: a Randomised, Controlled Trial
Run by Sklifosovsky Institute of Emergency Care · NCT05474573 · Data updated 2026-11-12
This study is testing whether using ultrasound along with a special dye can help doctors remove brain tumors more completely in patients with certain types of brain cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Sklifosovsky Institute of Emergency Care Government |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT05474573 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-79 with newly diagnosed contrast-enhancing gliomas or brain metastases and a Karnofsky Performance Status of 60-100%.
✕Probably not a fit
Patients with tumors spreading to critical brain areas, previous brain radiotherapy, or certain medical conditions such as hepatic or renal insufficiency may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of combining intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography in achieving a higher rate of complete tumor resection in patients with contrast-enhancing gliomas and brain metastases. Participants will be randomly assigned to receive either the combined approach or fluorescence-guided resection with 5-ALA alone. The extent of tumor resection will be assessed using postoperative MRI by blinded radiologists to determine the success of the interventions. This innovative approach seeks to overcome the limitations of current fluorescence-guided techniques.
Why it matters
Potential benefit: If successful, this approach could lead to more effective removal of brain tumors, potentially improving patient outcomes and survival rates.
How similar studies have gone: While there are published results comparing fluorescence-guided techniques, the combination with ultrasound represents a novel approach that has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Sklifosovsky Institute of Emergency Care
Moscow, Russia Recruiting
Study contacts
- Principal investigator: Alexander Dmitriev, MD — Sklifosovsky Institute of Emergency Care
- Study coordinator: Alexander Dmitriev, MD
- Email: dmitriev@neurosklif.ru
- Phone: +7 (916) 423-54-08
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.