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Light blast during brain surgery aims to fry leftover cancer cells

NCT ID NCT04391062

Disease control Sponsor: University Hospital, Lille 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether increasing the light dose during a special type of therapy called photodynamic therapy (PDT) is safe for people with glioblastoma, an aggressive brain cancer. Fourteen patients received a drug (5-ALA) before surgery, then a red laser was shone on the tumor bed after removal. The goal was to find the highest safe light dose. The treatment was added on top of standard care: surgery, radiation, and chemotherapy.

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) plus red light laser
What this could lead to
If successful, this could point toward a more effective way to destroy leftover cancer cells during brain tumor surgery, potentially delaying recurrence.
What could go wrong
This is a very small, early-phase study with only 14 participants. The main goal is to find a safe light dose, not to prove it works. Risks include brain swelling or damage from the light therapy.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

14 people

The number who actually took part.

Started

Sep 2021

Finished

Mar 2024

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: * General status (WHO) Karnofsky Performance Status ≥60 * Presumptive glioblastoma according to radiological criteria, * Surgical indication decided in Multidisciplinary consultation meeting (RCP) of neuro oncology, * Decision to treat the patient as part of the Clinical trial achieved in neuro-oncology RCP ("Multidisciplinary consultation meeting") * Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life * Clinical neuro-oncological monitoring and long-term MRI/ TEP 11C MET scheduled at the hospital centers * Patient able to understand and sign voluntarily Informed consent * Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol * Women of child-bearing potential should benefit of an effective contraception * For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA Exclusion Criteria: * Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT": * Contraindications to 5-ALA * Porphyria * Taking photosensitizer treatment * Severe renal or hepatic impairment * Bilirubin\> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)\> 2.5 x Maximum. rates * Creatinine clearance \<30 mL / min; * Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization * Contraindications to surgery * Contraindications to magnetic resonance imaging (MRI/TEP 11C MET * Treatment with an experimental drug within 30 Days prior to the start of the study * Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons, * Legal incapacity (persons deprived of their liberty or Guardianship or guardianship), * Pregnant or nursing women * Refusal to participate or sign the consent of the study * Soy allergy

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Conditions

The condition(s) this trial relates to.

glioblastoma neoplasm

As listed by the trial registrant

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

Glioblastoma

Contacts and locations

Locations

  • Hopital Roger Salengro, CHU Lille

    Lille, 59037, France

  • Hôpital Erasme, Clinique Universitaire de Bruxelles

    Brussels, Belgium

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