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.

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.

Sponsors & Collaborators

• Tampere University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Marginum Ltd.

  collaborator INDUSTRY

• Kuopio University Hospital

  lead OTHER

Principal Investigators

• Antti-Pekka Elomaa, Docent · Kuopio University Hospital

• Joonas Haapasalo, Docent · Tampere University Hospital

• Einar Vik-Mo, Professor · Oslo University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-30

Primary Completion

2028-09-01

Completion

2028-09-01

Countries

• Finland
• Norway

Study Locations