Actively Recruiting

Age: 18Years +
All Genders
ID06736470

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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