Surgical Suction Aspirates Fluorescence Measurement

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Admitted to neurosurgery department for surgical resection of a potential glioma

• Aged 18 years old or older

• Informed consent obtained

Locations
Other Locations
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Contact Information
Primary
Sami Puustinen, PhD
sami.puustinen@marginum.com
+358442190767
Backup
Antti-Pekka Elomaa, Docent
antti-pekka.elomaa@pshyvinvointialue.fi
Time Frame
Start Date: 2023-02-07
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 25
Treatments
5-ALA
Patients who are prescribed 5-ALA (n=13)
No 5-ALA
Patients who are not prescribed 5-ALA (n=7)
Related Therapeutic Areas
Sponsors
Collaborators: Marginum Ltd.
Leads: Kuopio University Hospital

This content was sourced from clinicaltrials.gov