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New camera aims to help surgeons spot brain tumor cells

NCT ID NCT07021573

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tests a special camera attached to a surgical microscope to see if it can better detect glioma tumor cells during brain surgery. Researchers will observe 80 adults with suspected high-grade gliomas. The goal is to improve how surgeons see tumor tissue, not to test a new drug or treatment.

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 could lead to better visualization of tumor cells during surgery, helping surgeons remove more of the tumor.
What could go wrong
This is an early observational study, not a treatment trial. The new imaging may not improve outcomes or could be impractical in real surgeries.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 99 years

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.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    10 sites in 3 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

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • Hôpitaux universitaires de Genève - NeuroCentre

    Geneva, Switzerland

  • Inselspital Bern, Universitätsklinik für Neurochirurgie

    Bern, Switzerland

  • Klinik und Poliklinik für Neurochirurgie, LMU Klinikum München

    München, Germany

  • Klinikum rechts der Isar der Technischen Universität München

    München, Germany

  • Universitätsklinik für Neurochirurgie der Medizinischen Universität Innsbruck

    Innsbruck, Austria

  • Universitätsklinikum Freiburg - Klinik für Neurochirurgie im Neurozentrum

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Göttingen - Neurochirurgische Klinik

    Göttingen, Germany

  • Universitätsklinikum Münster - Klinik für Neurochirurgie

    Münster, Germany

  • Universitätsklinikum Tübingen, Universitätsklinik für Neurochirurgie

    Tübingen, Germany

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