Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

NCT06740097 | Recruiting

• 1 other identifier: 5252675
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

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.

Conditions

High Grade Gliomas

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Extent of resection (EOR)

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

  four years

• Overall survival (OS)

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

  four years

• Progression-free survival (PFS)

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

  four years

• Karnofsky Performance Scale (KPS)

  Improved patients' postoperative performance KPS

  four years

• Amount of reoperations

  The effects on the amount of reoperations are investigated.

  four years

• Blood loss during the operation

  The effects on the blood loss during the operation (ml) are investigated.

  four years

• Duration of the operation

  The effects on the duration of the operation (min) are investigated.

  four years

Study Arms (2)

Aspirate tissue monitoring

EXPERIMENTAL

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.

Device: Aspirate tissue monitoring

Fluorescence-guided surgery

ACTIVE COMPARATOR

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

Device: Fluorescence-guided surgery

Interventions

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.

Aspirate tissue monitoring

Fluorescence-guided surgery DEVICE

Resection utilizing conventional visual fluorescence-guided surgery.

Fluorescence-guided surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient admitted to neurosurgery department for surgical resection of a suspected high-grade glioma
• Patients aged 18 years old or older
• Informed consent obtained

You may not qualify if:

• Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled

Sponsors & Collaborators

• Kuopio University Hospital: lead
• Tampere University Hospital: collaborator
• Oslo University Hospital: collaborator
• Marginum Ltd.: collaborator

Study Sites (3)

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, Finland

RECRUITING

Oslo University Hospital

Oslo, Norway

NOT YET RECRUITING

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Antti-Pekka Elomaa, Docent

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

• Joonas Haapasalo, Docent

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Einar Vik-Mo, Professor

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sami Puustinen, PhD

CONTACT

+358442190767; sami.puustinen@marginum.com

Antti-Pekka Elomaa, Docent

CONTACT

antti-pekka.elomaa@pshyvinvointialue.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: December 18, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 18, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); FI (2)