Protoporphyrin Imaging in Multispectral Evaluation of Resections

NCT07021573 | Not Yet Recruiting DMC

• 1 other identifier: PRIMER
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 10

Brief Summary

Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.

Conditions

Glioma

Keywords

Suspected high-grade gliomas

Outcome Measures

Primary Outcomes (1)

• Primary objective

  Detection of Tumor cells and fluorescence in biopsied tissue

  12 months

Secondary Outcomes (1)

• Secondary objectives

  12 months

Study Arms (1)

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.

Device: KINEVO 900 S with BLUE 400

Interventions

KINEVO 900 S with BLUE 400 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.

Also known as: CALLAO

GMB like or LGG like

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (10)

Universitätsklinik für Neurochirurgie der Medizinischen Universität Innsbruck

Innsbruck, Austria

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Freiburg - Klinik für Neurochirurgie im Neurozentrum

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Göttingen - Neurochirurgische Klinik

Göttingen, Germany

Location

Klinik und Poliklinik für Neurochirurgie, LMU Klinikum München

München, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

München, Germany

Location

Universitätsklinikum Münster - Klinik für Neurochirurgie

Münster, Germany

Location

Universitätsklinikum Tübingen, Universitätsklinik für Neurochirurgie

Tübingen, Germany

Location

Inselspital Bern, Universitätsklinik für Neurochirurgie

Bern, Switzerland

Location

Hôpitaux universitaires de Genève - NeuroCentre

Geneva, Switzerland

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Christian Freyschlag, Prof. Dr.

CONTACT

+43 (0)51250427463; christian.freyschlag@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 15, 2025
• Study Start: September 30, 2025
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); CH (2); AU (1)