Multicenter Phase II study with dose-light escalation, intraoperative glioblastoma photodynamic therapy - DOSINDYGO

CHU de Lille0 个研究点目标入组 21 人开始时间: 2021年1月27日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•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) yes
•F.1.3.1 Number of subjects for this age range 21

•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

发起方

CHU de Lille