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Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

ConditionHigh Grade Gliomas
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Aspirate tissue monitoringExperimental treatment 1 intervention
Group B: Fluorescence-guided surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Extent of resection (EOR)

The extent of resection (EOR) of the tumor is investigated.

Time frame
four years
2

Overall survival (OS)

The effects on the overall survival (OS) are investigated.

Time frame
four years
3

Progression-free survival (PFS)

The effects on the progression-free survival (PFS) are investigated.

Time frame
four years
4

Karnofsky Performance Scale (KPS)

Improved patients' postoperative performance KPS

Time frame
four years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kuopio University Hospital

Lead sponsor

Tampere University Hospital

Collaborator

Oslo University Hospital

Collaborator

Marginum Ltd.

Collaborator

Source ClinicalTrials.gov
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