Clinical trial · Interventional
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
NCT04391062CI-TRIAL-00098499DOSINDYGOcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gliolan | Drug | 5-Aminolevulinic Acid | ALIAS |
| Intraoperative PDT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- intraoperative PDT 400J/cm²
- interventionNames
- Drug: Gliolan
- Device: Intraoperative PDT
- type
- EXPERIMENTAL
- label
- intraoperative PDT 600J/cm²
- interventionNames
- Drug: Gliolan
- Device: Intraoperative PDT
- type
- EXPERIMENTAL
- label
- intraoperative PDT 800J/cm²
- interventionNames
- Drug: Gliolan
- Device: Intraoperative PDT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 allergyReferences
Publications (0)
Data not yet available
No reference posted for this study.