Actively Recruiting
Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery
Led by Kuopio University Hospital · Updated on 2024-12-18
50
Participants Needed
3
Research Sites
204 weeks
Total Duration
On this page
Sponsors
K
Kuopio University Hospital
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Kuopio University Hospital
Kuopio, Northern Savonia, Finland
Actively Recruiting
2
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Actively Recruiting
3
Oslo University Hospital
Oslo, Norway
Not Yet Recruiting
Research Team
S
Sami Puustinen, PhD
CONTACT
A
Antti-Pekka Elomaa, Docent
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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