Clinical Trial

Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

Study acronym: ATM GBM INT
Recruiting
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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.
Trial Details
NCT Number NCT06740097
Lead Sponsor Kuopio University Hospital
Collaborators: Tampere University Hospital, Oslo University Hospital, Marginum Ltd.
Conditions High Grade Gliomas
Enrollment 50 participants
Start Date 2024-09-30
Primary Completion 2028-09-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-18