Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers. (SHAM INDYGO/DO)

Adult patients with newly diagnosed resectable glioblastoma undergoing fluorescence-guided resection and chemoradiotherapy according to the STUPP protocol. The study includes a prospective control cohort treated with fluorescence-guided resection and chemoradiotherapy only (i.e., without photodynamic therapy (PDT)) and a historical prospective cohort previously treated with intraoperative PDT (INDYGO and DOSINDYGO trials) combined with fluorescence-guided resection and chemoradiotherapy. All patients receive standard post-operative Stupp protocol. Peripheral blood samples are analyzed for systemic immune profiling.

Inclusion Criteria:

• Patient male or female ≥18 years
• General status (WHO) of Performance status 0, 1 or 2
• Probable glioblastoma according to clinical and radiological criteria,
• whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
• Decision to treat the patient as part of the Clinical trial also taken 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 scheduled at the hospital CHRU of Lille, center of reference of the region
• 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
• Patient assigned to an health insurance

Exclusion Criteria:

• Contraindications to 5-ALA (Gliolan®)

  • 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)

• 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