Surgical Suction Aspirates Fluorescence Measurement

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKuopio University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to neurosurgery department for surgical resection of a potential glioma

Aged 18 years old or older

Informed consent obtained

Disqualifiers

Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled,,

Trial population

Patients from the Wellbeing Services County of North Savo region with a suspected glioma.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

25 Participants
are grouped into 2 trial groups
Group A: 5-ALA
Group B: No 5-ALA

Trial outcomes

Primary outcomes

1

Visual fluorescence

Operating surgeon's evaluation of the presence of visual fluorescence in each scene. The expert panel's opinion of the presence of visual fluorescence in each scene of the operating video.

Time frame
1 day (during surgical operation)
2

Fluorescence detected by the intestigational device

Fluorescence detected by the investigational device is compared against expert's visual detection.

Time frame
1 day (during surgical operation)

Secondary outcomes

Other outcomes

Sponsors and contacts

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