Surgical Suction Aspirates Fluorescence Measurement

Study Purpose

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 single-center observational study compares experts' visual detection of 5-ALA-induced fluorescence and fluorescence detected from the surgical suction waste. The fluorescence from the suction waste will not be reported back to the surgeon.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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,,

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06736470
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kuopio University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Antti-Pekka Elomaa, Docent
Principal Investigator Affiliation	Kuopio University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Finland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gliomas, High-grade Glioma

Additional Details

During glioma surgery, the diffuse boundary between healthy tissue and tumor is localized using 5-ALA drug-enhanced fluorescence of cancer cells. Visual fluorescence-based tissue recognition technique using 5-ALA has been shown to improve the rate of tumor removal and slow disease progression. To see the fluorescence typical of cancer, a special light source is needed in the operating microscope. In typical blue light, the fluorescence is visible, but it is more difficult detect anatomical landmarks, such as cerebral blood vessels and cranial nerves, which makes them vulnerable to injuries. Tumor cells can also be unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Unintended tumor remnants are frequent even though many other auxiliary techniques such as MRI guidance, neuronavigation, ultrasound and neurophysiological monitoring are used. This single center observational study investigates a novel medical device's performance to detect 5-ALA (PpIX) fluorescence from the surgical suction waste. The fluorescence detected by the device is compared to expert's visual evaluation of fluorescence using an operating microscope. The comparison includes the device's feedback, operating videos under blue and white light, anatomical location and the results of histopathological analysis. In total twenty-five (n=25) patients referred for resection surgery for suspected glioma or its recurrence at the Kuopio University Hospital. The patients are prescribed oral 5-ALA preoperatively according to the institution's practices and the suspected disease. Due to reasons not related to this study (lack of indication), some patients are not administered with 5-ALA. These patients are "control" patients providing reference data from brain tissues without exogenous fluorescent drugs to verify the device's safety and performance. Informed written consent will be obtained from patients to participate in the study on the new surgical device. The clinical trial is approved by the local research ethics committees and approved by the Finnish Medicines Agency (Fimea). The investigated device is not CE-marked.

Arms & Interventions

Arms

: 5-ALA

Patients who are prescribed 5-ALA (n=13)

: No 5-ALA

Patients who are not prescribed 5-ALA (n=7)

Interventions

Contact a Trial Team

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International Sites

Kuopio University Hospital, Kuopio, Finland

Status

Recruiting

Address

Kuopio University Hospital

Kuopio, , 70200

Site Contact

Antti-Pekka Elomaa, Docent

[email protected]

+358408339510

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