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Protoporphyrin Imaging in Multispectral Evaluation of Resections | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Protoporphyrin Imaging in Multispectral Evaluation of Resections

NCT07021573•Medical University Innsbruck

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+2 more criteria

Locations (10)

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

Key Dates

Start Date

September 30, 2025

Primary Completion Date

December 31, 2025

Completion Date

May 1, 2026

Last Updated

September 9, 2025

Enrollment

ESTIMATED participants

Conditions

Glioma

Interventions

KINEVO 900 S with BLUE 400

DEVICE

Contacts

Christian Freyschlag, Prof. Dr.

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Protoporphyrin Imaging in Multispectral Evaluation of Resections

Inclusion Criteria

Exclusion Criteria

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