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Glow-in-the-Dark dye could help brain cancer surgery

NCT ID NCT01811121

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a dye called 5-ALA, which makes tumor cells glow during surgery, helps surgeons remove more of a deadly brain cancer called glioblastoma. 170 adults with newly diagnosed glioblastoma were randomly assigned to receive either 5-ALA or a placebo before surgery. The main goal was to see if the dye led to more complete tumor removal, as seen on MRI scans.

What this could mean

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

Active substance
5-aminolevulinic acid (5-ALA)
What this could lead to
If successful, this could establish 5-ALA as a better tool for surgeons to remove more of the tumor during glioblastoma surgery, potentially improving survival.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely adopted. The benefit may be modest, and the technique requires specialized equipment and training.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

170 people

The number who actually took part.

Started

Feb 2013

Finished

Aug 2019

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 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.

Inclusion Criteria: * Age greater than 18 years with no upper age limit * Competent adult patient. * Patient affiliated to the National Health Insurance. * Patient with an intra-cerebral supra-tentorial hemispheric, newly diagnosed and previously untreated, which MRI characteristics are suggestive of a glioblastoma. * Indication for surgical treatment by excision. * Brain tumor location distant from critical functional areas allowing a wide resection of contrast enhancement on imaging, the a priori character completely resectable has been validated by an evaluation committee composed of three surgeons * No-cons contain medical surgery, ASA score below 4. * Patient eligible for further treatment by radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the so called Stupp scheme (standard protocol of adjuvant chemoradiotherapy) * Negative pregnancy test for women of childbearing age. Exclusion Criteria: * Contraindications to performing an MRI (pacemaker). * Glioblastoma known and previously treated with surgery, radiotherapy and / or chemotherapy. * History of cancer. * Anatomical Location of the tumor-cons indicating a wide excision, neurosurgeon at the discretion of medical officer participating center. * Location tumor in the brain stem, the middle line, the basal ganglia and the posterior cranial fossa. * Patient with cons-indication to the achievement of further treatment with radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the scheme proposed by Stupp. (1) * Patients with porphyria, renal insufficiency (creatinine\> 177 μmolL), liver insufficency(gamma glutamyl transpeptidase\> 100 U / L, prothrombin time \<60%, bilirubin\> 51μmol / L). * Patient refused to sign an informed consent form. * Ongoing participation of the patient to another clinical trial.

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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.

Contacts and locations

Locations

  • Guyotat

    Lyon, France

More trials for these conditions

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