Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (DOSINDYGO)

December 4, 2025 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Hôpital Erasme, Clinique Universitaire de Bruxelles
  • France
      • Lille, France, 59037
        • Hopital Roger Salengro, CHU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intraoperative PDT 400J/cm²
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).
Experimental: intraoperative PDT 600J/cm²
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).
Experimental: intraoperative PDT 800J/cm²
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)
Time Frame: 4 weeks (+/-3 days) post-PDT.
Dose level above which TDL is observed in more than 33% (i.e., d̀-> 2 of 6) of subjects in an arm
4 weeks (+/-3 days) post-PDT.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria
From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Global Progression Free Survival (PFS)
Time Frame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Median of progression-free survival time determined according to international RANO criteria
From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Overall Survival (OS)
Time Frame: From the Date of diagnosis of glioblastoma until the death, an average 18 months
Median of OS determined according to international RANO criteria
From the Date of diagnosis of glioblastoma until the death, an average 18 months
Response to treatment
Time Frame: every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months
Evaluated by MRI/ TEP 11C-MET every 3 months
every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months
Incidence of "intraoperative PDT" treatment-emergent Adverse Events
Time Frame: From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months
Collection of all Adverse events (AEs and SAEs) (according to NCI-CTCE V5.0) and reviewing by an Independent Safety Monitoring Board
From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months
Quality of Life Questionnaire -C30 ( QLQ-C30
Time Frame: Every 3 months from the signature of Consent form until relapse/death, an average 18 months
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items
Every 3 months from the signature of Consent form until relapse/death, an average 18 months
Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
Time Frame: Every 3 months from the signature of Consent form until relapse/death, an average 18 months
Measuring the health-related quality of life in patients with brain cancer
Every 3 months from the signature of Consent form until relapse/death, an average 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Hemerion Therapeutics

Investigators

  • Principal Investigator: Nicolas Reyns, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Actual)

March 25, 2024

Study Completion (Actual)

March 25, 2024

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_58
  • 2019-004796-40 (EudraCT Number)
  • 2019-A03157-50 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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