Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Russian Federation
Sklifosovsky Institute of Emergency Care
RECRUITING
Moscow
Contact Information
Primary
Alexander Dmitriev, MD
dmitriev@neurosklif.ru
+7 (916) 423-54-08
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 52
Treatments
Experimental: Fluorescence and Ultrasound
Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography
Active_comparator: Fluorescence
Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid
Related Therapeutic Areas
Sponsors
Leads: Sklifosovsky Institute of Emergency Care