Using ultrasound and fluorescence to improve brain tumor removal
Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Sklifosovsky Institute of Emergency Care Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05474573 on ClinicalTrials.gov |
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.
Who should consider this trial
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%.
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.
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 performed: While there are published results comparing fluorescence-guided techniques, the combination with ultrasound represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.