GLOW400-assisted neurosurgery for high-grade gliomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-interventional study collects real-world data across European sites to confirm the safety and performance of the GLOW400 accessory in fluorescence visualization during neurosurgical procedures for suspected grade III-IV gliomas. It compares GLOW400 visualization quality against the standard FL400 filter and tracks image quality, user experience, and safety, with an exploratory look at extent of resection using MRI. Data come from structured questionnaires, histopathology, optional resection forms, and intraoperative video, enrolling 37 patients and requiring at least 29 complete datasets over approximately 5–6 months. Participation relies on standard care procedures, ethics approval, and informed consent, with no additional interventions beyond routine surgery.

Why it matters

Who can join: the full rules

Candidates for the for the IMED-GLOW400 Study must be appropriate patients for surgical interventions with suspected intracranial high-grade glioma evidenced by preoperative imaging modalities and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.

Inclusion Criteria

1. Participants must be 18 years of age or older at the time of signing the informed consent.
2. Participants must have suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which require surgical intervention.
3. The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use.
4. The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study.

Note for Switzerland only:

Enrollment via legal representative is not permitted. Therefore, only patients who are capable of providing informed consent themselves will be eligible for inclusion in Switzerland.

Exclusion Criteria

1. Known allergy to 5-ALA hydrochloride or protoporphyrin.
2. Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
3. Any uncontrolled systemic condition that may adversely affect the surgical outcome.
4. Patients holding United States citizenship.

Where it's running

• Unidade Local de Saúde de São João
  Porto, Portugal Recruiting
• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Study coordinator: Leica Microsystems Clinical Affairs Department
• Email: clinical.affairs@leica-microsystems.com
• Phone: +41 796428004

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.