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New microscope gadget aims to sharpen brain tumor surgery

NCT ID NCT07366892

Knowledge-focused Sponsor: Leica Microsystems (Schweiz) AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special microscope accessory called GLOW400 that helps surgeons see glowing brain tumors during surgery. About 37 adults with suspected high-grade gliomas will take part. Surgeons will rate how well the device shows tumor fluorescence and image quality. The goal is to confirm the device works safely and effectively in routine care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this device could help surgeons remove brain tumors more precisely by improving how they see tumor fluorescence during surgery.
What could go wrong
This is a small, early-stage observational study focused on device performance, not on curing or treating the disease. It may not lead to better patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 37 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient population will include patients with suspected grade III or IV gliomas requiring surgical intervention, and who meet the Inclusion/Exclusion Criteria for the IMED-GLOW400 Study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

glioblastoma glioma malignant glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma (GBM) GLIOMA Neurosurgical procedure Suspected grade III and IV gliomas requiring surgical intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Unidade Local de Saúde de São João

    Porto, Portugal

  • University Hospital Basel

    Basel, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.