Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

Summary

Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. Surgeons use 5-aminolevulinic acid (5-ALA) drug-induced fluorescence to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are used to remove cancerous tissues, but so far the suction aspirate tissues have not been routinely used in tissue detection. This multicenter controlled clinical trial investigates the clinical performance and outcomes of a new method for detecting tumor from the suction aspirates in near-real time based on 5-ALA induced fluorescence. The feedback from the aspirate tissue monitor (ATM) is expected to improve the identification of tumors, leading to fewer reoperations and better treatment outcomes.

Interventions

• Aspirate tissue monitoring · DEVICE

  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 · DEVICE

  Resection utilizing conventional visual fluorescence-guided surgery.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Patient admitted to neurosurgery department for surgical resection of a suspected high-grade glioma
* Patients aged 18 years old or older
* Informed consent obtained

Exclusion Criteria:

* Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled

Sites (3)

• Kuopio University Hospital, Kuopio, Northern Savonia, Finland · RECRUITING
• Tampere University Hospital, Tampere, Pirkanmaa, Finland · RECRUITING
• Oslo University Hospital, Oslo, Norway · NOT_YET_RECRUITING