Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

NCT ID: NCT06740097

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2028-09-01

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.

Conditions

High Grade Gliomas

Keywords

aspirate tissue monitoring; high-grade glioma; 5-ALA; fluorescence-guided surgery; neurosurgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirate tissue monitoring

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 operated with the help of aspirate tissue monitoring and the controls without. Other preferred adjunct techniques are used in both groups.

Group Type: EXPERIMENTAL

Aspirate tissue monitoring

Intervention Type: 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

The cases are compared with controls (n=50) from applicable local clinical site registers (matched controls).

Group Type: ACTIVE_COMPARATOR

Fluorescence-guided surgery

Intervention Type: DEVICE

Resection utilizing conventional visual fluorescence-guided surgery.

Interventions

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.

Intervention Type: DEVICE

Fluorescence-guided surgery

Resection utilizing conventional visual fluorescence-guided surgery.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Marginum Ltd.

INDUSTRY

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antti-Pekka Elomaa, Docent

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Joonas Haapasalo, Docent

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Einar Vik-Mo, Professor

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status: RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status: RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: NOT_YET_RECRUITING

Countries

Finland; Norway

Central Contacts

Sami Puustinen, PhD

Role: CONTACT

Phone: +358442190767

Email: sami.puustinen@marginum.com

Antti-Pekka Elomaa, Docent

Role: CONTACT

Email: antti-pekka.elomaa@pshyvinvointialue.fi

Facility Contacts

Antti-Pekka Elomaa, Docent

Role: primary

Joonas Haapasalo, Docent

Role: primary

Einar Vik-Mo, Professor

Role: primary

References

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

Reference Type: BACKGROUND

Other Identifiers

5252675

Identifier Type: -

Identifier Source: org_study_id