Actively Recruiting
Surgical Suction Aspirates Fluorescence Measurement for Glioma Surgery
Led by Kuopio University Hospital · Updated on 2024-12-16
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kuopio University Hospital
Lead Sponsor
M
Marginum Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gliomas are tumors that can affect people of all ages and represent the most common malignant primary brain tumors in developed countries. They are often aggressive, and surgery combined with chemoradiation is the usual treatment. Complete removal is difficult due to the tumor's diffuse growth and closeness to important brain areas. Surgeons currently use a drug called 5-aminolevulinic acid (5-ALA) that makes tumor cells glow under special light, helping to detect and remove them, but some tumor cells can still be missed, leading to tumor return and additional surgeries. This observational study explores a new medical device that measures fluorescence from the surgical suction waste during glioma surgery. The device's fluorescence detection will be compared to experts' visual assessments of 5-ALA-induced fluorescence seen through an operating microscope. The study includes patients either given 5-ALA before surgery or not, serving as a control group. The device's fluorescence results will not be shared with the surgeon during the operation. Participants will undergo surgery with oral 5-ALA prescribed beforehand when indicated. Researchers will compare fluorescence detected by the device and by the surgeon's visual assessment during surgery, alongside video recordings and tissue analysis results. The study aims to better understand how well the device can detect tumor cells in suction waste. Consent is required, and safety and performance are closely monitored throughout the study period.
CONDITIONS
Brief Title
Surgical Suction Aspirates Fluorescence Measurement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to neurosurgery department for surgical resection of a potential glioma
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (during surgical operation)
Participants undergo glioma surgery during which fluorescence of cancer cells is measured using a special device and expert visual evaluation with an operating microscope.
1 surgical visit
Duration - Up to several days post-surgery
Participants are monitored after surgery with comparison of device feedback, operating videos, anatomical location, and histopathological results.
Additional assessments depending on clinical care
Trial Site Locations
Total: 1 location
1
Kuopio University Hospital
Kuopio, Kuopio, Finland, 70200
Actively Recruiting
Research Team
S
Sami Puustinen, PhD
A
Antti-Pekka Elomaa, Docent
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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