Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKuopio University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Patient admitted to neurosurgery department for surgical resection of a suspected high-grade glioma

Patients aged 18 years old or older

Informed consent obtained

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Aspirate tissue monitoring
  • Fluorescence-guided surgery

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kuopio University Hospital

Lead sponsor

Tampere University Hospital

Collaborator

Oslo University Hospital

Collaborator

Marginum Ltd.

Collaborator