NCT04391062

Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Gliolan	patient will receive 5-ALA 4 to 6 hours before surgery
DEVICE	Intraoperative PDT	The protocol requires the realization of specific procedures in addition to the usual care. The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).

Timeline

• Start date: 2021-09-28
• Primary completion: 2024-03-25
• Completion: 2024-03-25
• First posted: 2020-05-18
• Last updated: 2025-12-05

Locations

2 sites across 2 countries: Belgium, France