GliomaPRIMERNCT07021573
Protoporphyrin Imaging in Multispectral Evaluation of Resections
A study testing KINEVO 900 S with BLUE 400 in people with Glioma, run by Medical University Innsbruck at 10 sites in 3 countries.
Trial summary
Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioma
- What is being tested?
- KINEVO 900 S with BLUE 400
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 30 Sep 2025to 1 May 2026
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age Requirement: Patients must be 18 years of age or older.
- Diagnosis: Patients with a preoperative diagnosis of a suspected high-grade glioma based demographics and MRI imaging.
- MRI Findings: Patients must meet one of the following criteria:
- Group 1: Suspected high-grade glioma with contrast enhancement on MRI (GBM-like).
- Group 2: Suspected high-grade glioma without contrast enhancement on MRI (LGG-like).
- Surgical Resection: Patients scheduled to undergo surgical resection of the tumor as part of standard treatment.
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- 5-ALA Administration: Patients who will receive 5-aminolevulinic acid (5-ALA) for fluorescence guidance during surgery.
- Post-op MRI: Patients who are able to undergo pre- and postoperative MRI (standard of care at the center).
- Informed Consent: Patients who are able to understand and provide written informed consent prior to enrollment in the study.
- Eligibility for Multispectral Imaging: Patients whose surgical procedures allow for the use of multispectral imaging technology for tumor visualization.
- Performance Status: Patients with a Karnofsky Performance Status (KPS) of 60 or greater, indicating that they are capable of at least limited self-care.
- No Prior Treatment: Patients who have not received prior treatment for the current brain tumor, including surgery, radiotherapy, or chemotherapy.
Who cannot join
- Patients with a known allergy or contraindication to 5-aminolevulinic acid (5-ALA) or its components.
- Use of all other fluorescent markers.
- Patients with a history of porphyria or other disorders related to 5-ALA metabolism.
- Patients with recurrent gliomas or those who have received prior treatment for their current brain tumor, including surgery, radiotherapy, or chemotherapy.
- Pregnant or breastfeeding patients, due to potential risks associated with 5-ALA administration.
- Patients with severe comorbidities or other medical conditions that, in the investigator's opinion, would pose an unacceptable risk or compromise the safety of participation in the study.
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- Patients with a Karnofsky Performance Status (KPS) below 60, indicating an inability to perform minimal self-care.
- Patients with a history of severe hepatic or renal impairment that may impact the metabolism of 5-ALA.
- Patients unable to undergo MRI imaging for any reason (e.g., presence of non-MRI-compatible implants).
- Patients unable to provide written informed consent due to cognitive, language, or other barriers.
- Patients with tumors located in regions where fluorescence imaging is not technically feasible or where the use of multispectral imaging could interfere with the standard surgical approach.
- Pregnancy
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
Germany7 sites
Charité - Universitätsmedizin Berlin
Berlin
Anna-Gila Karbe, Dr.
Universitätsklinikum Freiburg - Klinik für Neurochirurgie im Neurozentrum
Freiburg im Breisgau
Roland Rölz, PD Dr.
Universitätsklinikum Göttingen - Neurochirurgische Klinik
Göttingen
Christoph Bettag, Dr.
Klinik und Poliklinik für Neurochirurgie, LMU Klinikum München
München
Florian Ringel, Prof. Dr.
Klinikum rechts der Isar der Technischen Universität München
München
Arthur Wagner, PD Dr.
Universitätsklinikum Münster - Klinik für Neurochirurgie
Münster
Eric Suero Molina, PD Dr.
Universitätsklinikum Tübingen, Universitätsklinik für Neurochirurgie
Tübingen
Constantin Röder, Prof. Dr.
Switzerland2 sites
Inselspital Bern, Universitätsklinik für Neurochirurgie
Bern
Andreas Raabe, Prof. Dr.
Hôpitaux universitaires de Genève - NeuroCentre
Geneva
Paul Constanthin, Dr.
Austria1 site
Universitätsklinik für Neurochirurgie der Medizinischen Universität Innsbruck
Innsbruck
Christian Freyschlag, Prof. PD Dr.
About this study
Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.
Read the detailed description
The clinical study is conducted in the post-market stage according to ISO 14155 Annex I.1 as it is performed with a CE marked microscope system. An additional component (CALLAO) will be added to the microscope. The intended use of the microscope as well as the surgical procedure remain unchanged by this addition. CALLAO allows for taking pictures of the situs in the OR which increases the surgery duration by <1min per picture. Therefore, this is a non-interventional study with a minimal burden to subjects.
The clinical investigation is not for a conformity assessment purpose. The burden to subjects is non-interventional.
- Conditions
- Glioma
- Being tested
- KINEVO 900 S with BLUE 400
- Keywords
- Suspected high-grade gliomas
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINEVO 900 S with BLUE 400Device
Also called CALLAO
The investigational device consists of a CE marked (MDR) surgical microscope KINEVO 900 S by Carl Zeiss Meditec AG, including the BLUE 400 fluorescence option. This microscope is equipped with an additional component (CALLAO), provided by the Carl Zeiss Meditec AG, that allows for extended, multispectral, image acquisition in the operating room. CALLAO consists of an optical setup with additional cameras, that can be mounted on the main system KINEVO 900 S, and a second light source for specific illumination during image acquisition with the CALLAO cameras.
| Study group | Role | What they receive |
|---|---|---|
| GMB like or LGG like | Other | There are 2 groups: group 1 (GBM-like) includes patients with high-grade gliomas and significant contrast enhancement on preoperative MRI. Group 2 (LGG-like) will include patients with suspected HGG and little to no contrast enhancement. Receives: Device: KINEVO 900 S with BLUE 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
Detection of Tumor cells and fluorescence in biopsied tissue
Measured: 12 months
Secondary outcomes (1)
Secondary objectives
Correlation with Histopathology, Diagnostic Performance Metrics, Molecular or Cellular Characterization, Clinical Correlation, Imaging Technology Performance, Impact on Clinical Decision-Making
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start30 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- There are 2 groups: group 1 (GBM-like) includes patients with high-grade gliomas and significant contrast enhancement on preoperative MRI. Group 2 (LGG-like) will include patients with suspected HGG and little to no contrast enhancement.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021573
- Sponsor's protocol ID
- PRIMER
- Acronym
- PRIMER
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protoporphyrin Imaging in Multispectral Evaluation of Resections
- ClinicalTrials.gov ID
- NCT07021573
- Acronym / sponsor ID
- PRIMER / PRIMER
- Conditions
- Glioma
- Keywords
- Suspected high-grade gliomas
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 15 Jun 2025 (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.
Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.
Detailed description
The clinical study is conducted in the post-market stage according to ISO 14155 Annex I.1 as it is performed with a CE marked microscope system. An additional component (CALLAO) will be added to the microscope. The intended use of the microscope as well as the surgical procedure remain unchanged by this addition. CALLAO allows for taking pictures of the situs in the OR which increases the surgery duration by <1min per picture. Therefore, this is a non-interventional study with a minimal burden to subjects.
The clinical investigation is not for a conformity assessment purpose. The burden to subjects is non-interventional.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There are 2 groups: group 1 (GBM-like) includes patients with high-grade gliomas and significant contrast enhancement on preoperative MRI. Group 2 (LGG-like) will include patients with suspected HGG and little to no contrast enhancement.
| Arm | Type | Receives |
|---|---|---|
| GMB like or LGG like | Other | Device: KINEVO 900 S with BLUE 400There are 2 groups: group 1 (GBM-like) includes patients with high-grade gliomas and significant contrast enhancement on preoperative MRI. Group 2 (LGG-like) will include patients with suspected HGG and little to no contrast enhancement. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age Requirement: Patients must be 18 years of age or older.
- Diagnosis: Patients with a preoperative diagnosis of a suspected high-grade glioma based demographics and MRI imaging.
- MRI Findings: Patients must meet one of the following criteria:
- Surgical Resection: Patients scheduled to undergo surgical resection of the tumor as part of standard treatment.
- 5-ALA Administration: Patients who will receive 5-aminolevulinic acid (5-ALA) for fluorescence guidance during surgery.
Key exclusion criteria (12 listed)
- Patients with a known allergy or contraindication to 5-aminolevulinic acid (5-ALA) or its components.
- Use of all other fluorescent markers.
- Patients with a history of porphyria or other disorders related to 5-ALA metabolism.
- Patients with recurrent gliomas or those who have received prior treatment for their current brain tumor, including surgery, radiotherapy, or chemotherapy.
- Pregnant or breastfeeding patients, due to potential risks associated with 5-ALA administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KINEVO 900 S with BLUE 400Also: CALLAOThe investigational device consists of a CE marked (MDR) surgical microscope KINEVO 900 S by Carl Zeiss Meditec AG, including the BLUE 400 fluorescence option. This microscope is equipped with an additional component (CALLAO), provided by the Carl Zeiss Meditec AG, that allows for extended, multispectral, image acquisition in the operating room. CALLAO consists of an optical setup with additional cameras, that can be mounted on the main system KINEVO 900 S, and a second light source for specific illumination during image acquisition with the CALLAO cameras. | Device | GMB like or LGG like |
Primary outcome
Primary objective
Time frame: 12 months
Detection of Tumor cells and fluorescence in biopsied tissue
1 secondary outcome
Secondary objectives
Time frame: 12 months
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 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KINEVO 900 S with BLUE 400 in people with Glioma, run by Medical University Innsbruck at 10 sites in 3 countries.
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 12 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Switzerland, Austria. 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 Christian Freyschlag, Prof. Dr. (+43 (0)51250427463, christian.freyschlag@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: 12 months). 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 9 Sep 2025.