Surgical Suction Aspirates Fluorescence Measurement

NCT06736470 | Recruiting DMC

• 1 other identifier: 5252665
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gliomas; High-grade Glioma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

5-ALA

Patients who are prescribed 5-ALA (n=13)

No 5-ALA

Patients who are not prescribed 5-ALA (n=7)

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Admitted to neurosurgery department for surgical resection of a potential glioma
• 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
• Marginum Ltd.: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Kuopio, 70200, Finland

RECRUITING

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

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: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 16, 2024
• Study Start: February 7, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)