During glioma surgery, the diffuse boundary between healthy tissue and tumor is localized
using 5-ALA drug-enhanced fluorescence of cancer cells. Visual fluorescence-based tissue
recognition technique using 5-ALA has been shown to improve the rate of tumor removal and
slow disease progression. To see the fluorescence typical of cancer, a special light
source is needed in the operating microscope. In typical blue light, the fluorescence is
visible, but it is more difficult detect anatomical landmarks, such as cerebral blood
vessels and cranial nerves, which makes them vulnerable to injuries. Tumor cells can also
be unnoticed because of visual obstacles or weak fluorescence, which may lead to local
recurrence and reoperations. Unintended tumor remnants are frequent even though many
other auxiliary techniques such as MRI guidance, neuronavigation, ultrasound and
neurophysiological monitoring are used.
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.
In total fifty (n=50) patients referred for resection surgery for suspected high-grade
glioma or its recurrence at the Kuopio University Hospital, Tampere University Hospital
and Oslo University Hospital, and potential other trial sites, will be recruited to the
study. The patients are prescribed oral 5-ALA preoperatively according to the
institution's practices. 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.
Informed written consent will be obtained from patients to participate in the study on
the new surgical device. The clinical trial is approved by the local research ethics
committees and approved by the Finnish Medicines Agency (Fimea) and Norwegian Medicines
Agency (NoMA). Patients are asked for permission to pool unidentified study data from
surgical patients collected at different research institutions. The investigated device
is a CE equivalent or CE marked.