50
Participants
Start Date
September 30, 2024
Primary Completion Date
September 1, 2028
Study Completion Date
September 1, 2028
Aspirate tissue monitoring
This multicenter controlled clinical trial investigates the clinical performance and outcomes from using an aspirate tissue monitor (ATM, Marginum Ltd HIVEN™) that detects cancerous tissue from the suction waste during the surgical treatment of suspected high-grade gliomas. The ATM provides near real-time audible feedback to the surgeon when tumor-related fluorescence is detected in the aspirated tissues. The trial investigates if the use of ATM to detect 5-ALA induced fluorescence contributes to faster tumor removal, less blood loss, less unintended residual tumor, less morbidity, longer survival and the frequency of local reoperations. The cases are compared with controls (n=50) from applicable local clinical site registers (matched controls). The cases are operated with the help of aspirate tissue monitoring and the controls without. Other preferred adjunct techniques are used in both groups.
Fluorescence-guided surgery
Resection utilizing conventional visual fluorescence-guided surgery.
RECRUITING
Kuopio University Hospital, Kuopio
RECRUITING
Tampere University Hospital, Tampere
NOT_YET_RECRUITING
Oslo University Hospital, Oslo
Tampere University Hospital
OTHER
Oslo University Hospital
OTHER
Marginum Ltd.
INDUSTRY
Kuopio University Hospital
OTHER