Light therapy during brain surgery shows promise for glioblastoma
NCT ID NCT03048240
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested whether a light-activated drug (5-ALA) could be safely used during brain surgery to treat glioblastoma, an aggressive brain cancer. Ten adult patients received this experimental therapy in addition to standard surgery and chemoradiation. The main goal was to see if the treatment was feasible and did not cause severe side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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10 people
The number who actually took part.
- Started
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May 2017
- Finished
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Apr 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient male or female ≥18 years 2. General status (WHO) of Performance status 0, 1 or 2 3. Probable glioblastoma according to clinical and radiological criteria, 4. whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology, 5. Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting") 6. 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 7. Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region 8. Patient able to understand and sign voluntarily Informed consent 9. Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol 10. Women of child-bearing potential should benefit of an effective contraception 11. For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA 12. Patient assigned to an heath insurance Exclusion Criteria: 1. Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT": 2. 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 3. Contraindications to surgery 4. Contraindications to magnetic resonance imaging (MRI) 5. Treatment with an experimental drug within 30 Days prior to the start of the study 6. Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons, 7. Legal incapacity (persons deprived of their liberty or Guardianship or guardianship), 8. Pregnant or nursing women 9. Refusal to participate or sign the consent of the study 10. Soy allergy
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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
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Hôpital Roger Salengro, CHRU
Lille, France
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