Glioblastoma photodynamic therapy

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 21

Inclusion Criteria

1. Patient male or female age =18 years
2. Free and informed consent of the patient with signature of the consent form participation in the study after submission of the information note.
3. General health status - Karnofsky score =60
4. Probable glioblastoma according to clinical criteria and MRI whose indication of surgical load was posed in CPR neuro-oncology.
5. Decision to treat the patient as part of the clinical trial also taken in CPR neuro-oncology
6. Patient operable on the basis of absence of cardiopulmonary history, or balance sheet providing sufficient post-operative status for normal daily life.
7. Clinical neuro-oncological follow-up and MRI (T1, T1 Gado, T2, FLAIR) at long planned course in the participating center.
8. Patient able to understand the briefing note, to voluntarily sign a informed consent and to adhere to the study program for the study and to others imperatives of the protocol.
9. Effective contraception for women of childbearing age to avoid pregnancy during the study.
10. For patients receiving long-term hepatotoxic treatment, this treatment must be able to be hung for 24 hours after taking 5-ALA
11. Quality of social insurance or social security entitlement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Contraindications to 5-ALA or intraoperative PDT
2. Legal incapacity (persons deprived of their liberty or under guardianship or curatorship)
3. Contraindications to MRI and / or TEP 11C MET
4. Treatment with an experimental drug in the 30 days prior to the start of the study,
5. Clinical follow-up impossible for psychological, family, social or geographical reasons,
6. Pregnant or lactating woman
7. Refusal to participate or sign consent
8. Soy Allergy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the Maximum Tolerated Light-Dose defined as the associated light-dose at a rate of Toxicities Limit-Dose (TLD) acceptable up to 4 weeks +/- 3 days post perPDT.;Secondary Objective: Secondary objectives are to evaluate:<br>- Progression-free survival (PFS) in the 25mm of operating margins<br>- Progression-free survival (PFS)<br>- Overall survival (OS)<br>- Tolerance (Toxicity of the perPDT)<br>- Response to treatment by Imaging<br>- Quality of life<br>-Evaluation of potential biomarkers of therapy;Primary end point(s): Please see French section;Timepoint(s) of evaluation of this end point: Please see French section

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Please see French section;Timepoint(s) of evaluation of this end point: At the end of study

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