Protoporphyrin Imaging in Multispectral Evaluation of Resections

NCT ID: NCT07021573

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-05-01

Brief Summary

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.

Conditions

Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

GMB like or LGG like

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.

Group Type: OTHER

KINEVO 900 S with BLUE 400

Intervention Type: DEVICE

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.

Interventions

KINEVO 900 S with BLUE 400

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.

Intervention Type: DEVICE

Other Intervention Names

CALLAO

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik für Neurochirurgie der Medizinischen Universität Innsbruck

Innsbruck, , Austria

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Universitätsklinikum Freiburg - Klinik für Neurochirurgie im Neurozentrum

Freiburg im Breisgau, , Germany

Universitätsklinikum Göttingen - Neurochirurgische Klinik

Göttingen, , Germany

Klinik und Poliklinik für Neurochirurgie, LMU Klinikum München

München, , Germany

Klinikum rechts der Isar der Technischen Universität München

München, , Germany

Universitätsklinikum Münster - Klinik für Neurochirurgie

Münster, , Germany

Universitätsklinikum Tübingen, Universitätsklinik für Neurochirurgie

Tübingen, , Germany

Inselspital Bern, Universitätsklinik für Neurochirurgie

Bern, , Switzerland

Hôpitaux universitaires de Genève - NeuroCentre

Geneva, , Switzerland

Countries

Austria; Germany; Switzerland

Central Contacts

Christian Freyschlag, Prof. Dr.

Role: CONTACT

christian.freyschlag@i-med.ac.at

+43 (0)51250427463

Facility Contacts

Christian Freyschlag, Prof. PD Dr.

Role: primary

Anna-Gila Karbe, Dr.

Role: primary

Roland Rölz, PD Dr.

Role: primary

Christoph Bettag, Dr.

Role: primary

Florian Ringel, Prof. Dr.

Role: primary

Arthur Wagner, PD Dr.

Role: primary

Eric Suero Molina, PD Dr.

Role: primary

Constantin Röder, Prof. Dr.

Role: primary

Andreas Raabe, Prof. Dr.

Role: primary

Paul Constanthin, Dr.

Role: primary

Other Identifiers

PRIMER

Identifier Type: -

Identifier Source: org_study_id