Clinical trial NCT06740097: Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery
Official title: Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Grade Gliomas
Keywords: aspirate tissue monitoring
high-grade glioma
5-ALA
fluorescence-guided surgery
neurosurgery
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Oslo University Hospital
name: Marginum Ltd.
First posted: 2024-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: During glioma surgery, the diffuse boundary between healthy tissue and tumor is localized using 5-ALA drug-enhanced fluorescence of cancer cells. Visual fluorescence-based tissue recognition technique using 5-ALA has been shown to improve the rate of tumor removal and slow disease progression. To see the fluorescence typical of cancer, a special light source is needed in the operating microscope. In typical blue light, the fluorescence is visible, but it is more difficult detect anatomical landmarks, such as cerebral blood vessels and cranial nerves, which makes them vulnerable to injuries. Tumor cells can also be unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Unintended tumor remnants are frequent even though many other auxiliary techniques such as MRI guidance, neuronavigation, ultrasound and neurophysiological monitoring are used.

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.

In total fifty (n=50) patients referred for resection surgery for suspected high-grade glioma or its recurrence at the Kuopio University Hospital, Tampere University Hospital and Oslo University Hospital, and potential other trial sites, will be recruited to the study. The patients are prescribed oral 5-ALA preoperatively according to the institution's practices. 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.

Informed written consent will be obtained from patients to participate in the study on the new surgical device. The clinical trial is approved by the local research ethics committees and approved by the Finnish Medicines Agency (Fimea) and Norwegian Medicines Agency (NoMA). Patients are asked for permission to pool unidentified study data from surgical patients collected at different research institutions. The investigated device is a CE equivalent or CE marked.

Eligibility criteria: 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

Primary outcomes:
measure: Extent of resection (EOR)
timeFrame: four years
measure: Overall survival (OS)
timeFrame: four years
measure: Progression-free survival (PFS)
timeFrame: four years
measure: Karnofsky Performance Scale (KPS)
timeFrame: four years
measure: Amount of reoperations
timeFrame: four years
measure: Blood loss during the operation
timeFrame: four years
measure: Duration of the operation
timeFrame: four years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Pohjois-Savo
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Antti-Pekka Elomaa, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Joonas Haapasalo, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Einar Vik-Mo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Intraoperative aspirate tissue monitoring during 5-ALA fluorescence-guided surgery of high-grade glioma - the first-in-human observational cases https://doi.org/10.1016/j.bas.2023.102121