NCT04391062CompletedPhase 2

Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

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

Source: ClinicalTrials.gov · Last updated 5 Dec 2025

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 14 (actual)
First submitted: 12 May 2020
Start date: 28 Sept 2021
Primary completion date: 25 Mar 2024
Lead sponsor: University Hospital, Lille
Diseases: Glioblastoma
NCT number: NCT04391062
EudraCT number: 2019-004796-40

What you commit to

Study type: Interventional · Phase 2
Participants enrolled: 14
From 28 Sept 2021 to the primary completion date, 25 Mar 2024
2 sites in 2 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
Contraindications to surgery
Treatment with an experimental drug within 30 Days prior to the start of the study

Other illness

Soy allergy

Lab values

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

Other

Contraindications to magnetic resonance imaging (MRI/TEP 11C MET
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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Hôpital Erasme, Clinique Universitaire de Bruxelles Coordinator of this site? Confirm its status	Brussels	Belgium	Unknown status
Hopital Roger Salengro, CHU Lille Coordinator of this site? Confirm its status	Lille	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.