Glow-in-the-Dark dye could help brain cancer surgery
NCT ID NCT01811121
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 Hide 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
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