Surgical Suction Aspirates Fluorescence Measurement (ATM GBM)

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 single-center observational study compares experts' visual detection of 5-ALA-induced fluorescence and fluorescence detected from the surgical suction waste. The fluorescence from the suction waste will not be reported back to the surgeon.

Study Overview

• Status: Recruiting
• Conditions: High-grade Glioma; Gliomas

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 single center observational study investigates a novel medical device's performance to detect 5-ALA (PpIX) fluorescence from the surgical suction waste. The fluorescence detected by the device is compared to expert's visual evaluation of fluorescence using an operating microscope. The comparison includes the device's feedback, operating videos under blue and white light, anatomical location and the results of histopathological analysis.

In total twenty-five (n=25) patients referred for resection surgery for suspected glioma or its recurrence at the Kuopio University Hospital. The patients are prescribed oral 5-ALA preoperatively according to the institution's practices and the suspected disease. Due to reasons not related to this study (lack of indication), some patients are not administered with 5-ALA. These patients are "control" patients providing reference data from brain tissues without exogenous fluorescent drugs to verify the device's safety and performance.

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). The investigated device is not CE-marked.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Sami Puustinen, PhD; Phone Number: +358442190767; Email: sami.puustinen@marginum.com
• Study Contact Backup: Name: Antti-Pekka Elomaa, Docent; Email: antti-pekka.elomaa@pshyvinvointialue.fi

Study Locations

• Finland
  • Kuopio, Finland, 70200
    • Recruiting
    • Kuopio University Hospital
    • Contact: Antti-Pekka Elomaa, Docent; Phone Number: +358408339510; Email: antti-pekka.elomaa@pshyvinvointialue.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from the Wellbeing Services County of North Savo region with a suspected glioma.

Description

Inclusion Criteria:

• Admitted to neurosurgery department for surgical resection of a potential glioma
• Aged 18 years old or older
• Informed consent obtained

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
5-ALA; Patients who are prescribed 5-ALA (n=13)
No 5-ALA; Patients who are not prescribed 5-ALA (n=7)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual fluorescence	Operating surgeon's evaluation of the presence of visual fluorescence in each scene. The expert panel's opinion of the presence of visual fluorescence in each scene of the operating video.	1 day (during surgical operation)
Fluorescence detected by the intestigational device	Fluorescence detected by the investigational device is compared against expert's visual detection.	1 day (during surgical operation)

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: Marginum Ltd.
• Investigators: Principal Investigator: Antti-Pekka Elomaa, Docent, Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: 5-ALA; high-grade glioma; neurosurgery; fluorescence-guided surgery; aspirate tissue monitoring
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 5252665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Potential GDPR limitations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No