Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

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

• Patient admitted to neurosurgery department for surgical resection of a suspected high-grade glioma

• Patients aged 18 years old or older

• Informed consent obtained

Locations
Other Locations
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Tampere University Hospital
RECRUITING
Tampere
Norway
Oslo University Hospital
NOT_YET_RECRUITING
Oslo
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: 2024-09-30
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 50
Treatments
Experimental: 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.
Active_comparator: Fluorescence-guided surgery
The cases are compared with controls (n=50) from applicable local clinical site registers (matched controls).
Related Therapeutic Areas
Sponsors
Collaborators: Tampere University Hospital, Oslo University Hospital, Marginum Ltd.
Leads: Kuopio University Hospital

This content was sourced from clinicaltrials.gov