Clinical trial · Interventional
INtraoperative photoDYnamic Therapy of GliOblastoma
A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.
NCT03048240CI-TRIAL-00102589INDYGOcompletedN/AClinicalTrials.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 study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp
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 |
| "perPDT" | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- "perPDT"
- description
- Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
- interventionNames
- Device: "perPDT"
- Drug: GLIOLAN
Primary outcomes (1)
- measure
- Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0
- timeFrame
- From the intake of Gliolan (5-Ala) until 1 month post "perPDT"
- description
- In particular, the following complications will be investigated: severe infection, new neurological deficit responsible for severe disability, status epilepticus, deaths during the postoperative period. Target: At least 6/10 patients who benefited of complete "PerPDT" and without unacceptable and unexpected toxicities
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 allergyReferences
Publications (2)
- RESULTVermandel M, Dupont C, Lecomte F, Leroy HA, Tuleasca C, Mordon S, Hadjipanayis CG, Reyns N. Standardized intraoperative 5-ALA photodynamic therapy for newly diagnosed glioblastoma patients: a preliminary analysis of the INDYGO clinical trial. J Neurooncol. 2021 May;152(3):501-514. doi: 10.1007/s11060-021-03718-6. Epub 2021 Mar 20. PMID 33743128
- DERIVEDPeciu-Florianu I, Vannod-Michel Q, Vauleon E, Bonneterre ME, Reyns N. Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240). J Neurooncol. 2024 Jul;168(3):495-505. doi: 10.1007/s11060-024-04693-4. Epub 2024 May 16. PMID 38753093