GliomasATM GBMNCT06736470
Surgical Suction Aspirates Fluorescence Measurement
An observational study of Gliomas and High-grade Glioma, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gliomas, High-grade Glioma
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- 7 Feb 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Wellbeing Services County of North Savo region with a suspected glioma.
Who may be able to join
- Admitted to neurosurgery department for surgical resection of a potential glioma
- Aged 18 years old or older
- Informed consent obtained
Who cannot join
- Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled,,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antti-Pekka Elomaa, Docent contact
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, Kuopio, 70200
Antti-Pekka Elomaa, Docent, +358408339510, antti-pekka.elomaa@pshyvinvointialue.fi
About this study
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.
Read the detailed description
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.
- Conditions
- Gliomas, High-grade Glioma
- Keywords
- aspirate tissue monitoring, high-grade glioma, 5-ALA, fluorescence-guided surgery, neurosurgery
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 5-ALA | Patients who are prescribed 5-ALA (n=13) | |
| No 5-ALA | Patients who are not prescribed 5-ALA (n=7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (during surgical operation)
Fluorescence detected by the intestigational device
Fluorescence detected by the investigational device is compared against expert's visual detection.
Measured: 1 day (during surgical operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start7 Feb 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Marginum Ltd.
- Responsible party
- Sponsor
- Investigators
- Antti-Pekka Elomaa, Docent, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736470
- Sponsor's protocol ID
- 5252665
- Acronym
- ATM GBM
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Potential GDPR limitations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Suction Aspirates Fluorescence Measurement
- ClinicalTrials.gov ID
- NCT06736470
- Acronym / sponsor ID
- ATM GBM / 5252665
- Conditions
- Gliomas, High-grade Glioma
- Keywords
- aspirate tissue monitoring, high-grade glioma, 5-ALA, fluorescence-guided surgery, neurosurgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Marginum Ltd.
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-ALA | – | –Patients who are prescribed 5-ALA (n=13) |
| No 5-ALA | – | –Patients who are not prescribed 5-ALA (n=7) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Wellbeing Services County of North Savo region with a suspected glioma.
Key inclusion criteria (3 listed)
- Admitted to neurosurgery department for surgical resection of a potential glioma
- Aged 18 years old or older
- Informed consent obtained
Key exclusion criteria (1 listed)
- Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled,,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual fluorescence
Time frame: 1 day (during surgical operation)
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.
Fluorescence detected by the intestigational device
Time frame: 1 day (during surgical operation)
Fluorescence detected by the investigational device is compared against expert's visual detection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No. Potential GDPR limitations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antti-Pekka Elomaa, Docent contact
Antti-Pekka Elomaa, Docent principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gliomas and High-grade Glioma, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sami Puustinen, PhD (+358442190767, sami.puustinen@marginum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual fluorescence (time frame: 1 day (during surgical operation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.