Measuring fluorescence from surgical suction during glioma surgery
Surgical Suction Aspirates Fluorescence Measurement
This study is testing a new device that measures fluorescence from surgical suction during glioma surgery to see if it helps doctors remove more tumor tissue compared to what they can see with their regular tools.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kuopio University Hospital Academic / other |
| Locations | 1 site (Kuopio, Kuopio) |
| Trial ID | NCT06736470 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of a novel device that detects fluorescence from surgical suction waste during glioma surgeries. The study aims to compare the fluorescence detected by this device with the visual evaluation performed by experts using an operating microscope, which utilizes 5-aminolevulinic acid (5-ALA) to enhance tumor visibility. By analyzing the fluorescence feedback, operating videos, and histopathological results, the study seeks to improve tumor resection rates and reduce the chances of local recurrence. A total of 25 patients undergoing surgery for suspected glioma or its recurrence at Kuopio University Hospital will be included in the study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for surgical resection of a suspected glioma.
Not a fit: Patients who are part of vulnerable groups, such as children, pregnant individuals, prisoners, or those with intellectual disabilities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of tumor removal during surgery, potentially leading to better patient outcomes and reduced recurrence rates.
How similar studies have performed: While the use of 5-ALA for fluorescence-guided surgery has shown success in previous studies, the specific approach of analyzing suction aspirate fluorescence is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted to neurosurgery department for surgical resection of a potential glioma * Aged 18 years old or older * Informed consent obtained Exclusion Criteria: * Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled,,
Where this trial is running
Kuopio, Kuopio
- Kuopio University Hospital — Kuopio, Kuopio, Finland (Recruiting)
Study contacts
- Principal investigator: Antti-Pekka Elomaa, Docent — Kuopio University Hospital
- Study coordinator: Sami Puustinen, PhD
- Email: sami.puustinen@marginum.com
- Phone: +358442190767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.