Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

September 1, 2028

Study Completion Date

September 1, 2028

Conditions
High Grade Gliomas
Interventions
DEVICE

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.

DEVICE

Fluorescence-guided surgery

Resection utilizing conventional visual fluorescence-guided surgery.

Trial Locations (3)

Unknown

RECRUITING

Kuopio University Hospital, Kuopio

RECRUITING

Tampere University Hospital, Tampere

NOT_YET_RECRUITING

Oslo University Hospital, Oslo

All Listed Sponsors
collaborator

Tampere University Hospital

OTHER

collaborator

Oslo University Hospital

OTHER

collaborator

Marginum Ltd.

INDUSTRY

lead

Kuopio University Hospital

OTHER